116 Regulatory Submissions Jobs

The Senior Associate Regulatory Project & Resource Management plays a crucial role in supporting and streamlining regulatory projects within the organization. Your responsibilities will include coordinating tasks related to regulatory submissions and compliance, ensuring projects are completed within specified timeframes while upholding industry standards and regulations. This role requires keen attention to detail and strong project management skills. You will collaborate with cross-functional teams to allocate resources efficiently and manage communication streams, ensuring precise and timely adherence to regulations. This position offers opportunities for growth and development in a dynamic environment centered around regulatory affairs. Responsibilities Coordinate and manage regulatory projects for timely and efficient completion. Develop and maintain project timelines and resource allocation plans. Collaborate with cross-functional teams to align regulatory strategies and deliverables. Monitor project progress, promptly addressing any issues or delays. Conduct risk assessments for potential regulatory compliance issues. Prepare and review regulatory documentation and submissions for accuracy. Liaise with regulatory bodies to facilitate communication and approvals. Track and report metrics related to project outcomes and resource utilization. Ensure compliance with all regulatory requirements and company policies. Support the development and implementation of process improvements in regulatory affairs. Assist in training and mentoring junior team members in regulatory processes. Organize and participate in regulatory meetings and project reviews. Requirements Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field. 3-5 years of experience in regulatory project management. Strong understanding of global regulatory requirements and submission processes. Excellent organizational skills to manage multiple projects effectively. Proficiency in using project management tools and software applications. Exceptional communication skills, both verbal and written, with various stakeholders. Ability to work independently and collaboratively in a team setting. If you are passionate about regulatory affairs and possess the necessary qualifications and experience, we encourage you to apply for this role. Join our team in Maharashtra, India, and be part of a company deeply committed to regulatory excellence. About The Company TALENTMATE Portal aims to simplify the professional life by bringing together job seekers and potential employers under one roof. Whether you are seeking your next job opportunity or looking for talented professionals, we are here to support and guide you through the process. (Note: This job description is a standard summary of the role's responsibilities and requirements. For more details, visit our company website at https://www.talentmate.com),

As an Analytical Development Manager, you will be responsible for leading and executing analytical activities related to formulation development projects. Your role will involve developing and validating analytical methods, conducting testing to support formulation development and regulatory submissions, ensuring data integrity and compliance with GMP guidelines, and collaborating with various departments and external partners. You will also be involved in maintaining and calibrating analytical instruments and assisting in method transfer and troubleshooting. Key Responsibilities: - Develop and validate analytical methods for assay, dissolution, related substances, and other QC parameters. - Conduct analytical testing to support formulation development, stability studies, and regulatory submissions. - Ensure data integrity, GMP compliance, and adherence to ICH, USP/Ph. Eur. guidelines. - Collaborate with Formulation, QA, RA, and external manufacturing/testing partners. - Prepare and review analytical protocols, reports, specifications, and method transfer documents. - Assist in method transfer and analytical troubleshooting at CMOs or partner labs. - Maintain and calibrate analytical instruments (HPLC, GC, UV, IR, etc.) Required Qualifications: - M.Pharm / M.Sc in Pharmaceutical Chemistry, Analytical Chemistry, or related field. - 3-7 years of hands-on experience in analytical method development and validation for small molecule generic drugs. - Familiarity with ICH guidelines, regulatory documentation, and stability protocols. - Experience working with common lab instruments like HPLC, GC, Dissolution testers, etc. - Strong technical documentation and analytical reasoning skills. Preferred Experience: - Exposure to regulated market requirements (USFDA, EMA). - Experience in handling OOS/OOT investigations and change controls. - Prior experience with technology transfer or working with CMOs is a plus.,

Job Title: Senior Executive Regulatory Affairs Experience: 5 to 7 Years Salary: Max 10 LPA Location: Sion, Mumbai Department: Regulatory Affairs Should be from the Pharmaceutical /Lifesciences Industry. Job Overview: We are looking for an experienced and detail-oriented Senior Executive Regulatory Affairs (RA) to join our team. The ideal candidate will be responsible for compiling, reviewing, and submitting regulatory dossiers for both ROW and regulated markets in compliance with EU CTD guidelines. This role demands a strong understanding of global regulatory requirements, coordination across cross-functional teams, and the ability to independently handle client and authority queries. Key Responsibilities: Prepare master dossiers as per EU CTD (Common Technical Document) guidance. Review key regulatory documents including: Product Development Reports (PDR) Specifications and STPs for excipients, APIs, and finished products Control Drug Processes (CDP) Nitrosamine risk assessments Elemental and residual impurity reports Assessment reports, stability protocols, and reports Process validation protocols and reports Drug Master Files (DMFs) Submit regulatory dossiers across ROW (Zambia, Peru, Ethiopia, Canada, Singapore, Malaysia, Venezuela, Philippines) and Regulated markets (EU, UK, Brazi , AUS) . Handle and respond to MoH (Ministry of Health) and client queries in a timely and compliant manner. Coordinate with clients for regulatory meetings and calls. Collaborate effectively with internal teams including Plant, Project Management (PM), R&&D, FRD, and external stakeholders like CROs && CMOs. Review dossiers prepared by junior team members and provide necessary guidance. Handle EU variation filings for Type IA, IB, and Type II submissions. Maintain proper registration databases and submission records. Required Skills & Qualifications : B. Sc B.Pharm / M.Pharm / M.Sc in a relevant discipline. 5 to 7 years of hands-on experience in Regulatory Affairs, preferably in pharmaceutical formulations. Strong knowledge of EU CTD format and global regulatory guidelines. Proficiency in dossier compilation and review for regulated and semi-regulated markets. Experience with variation filings and managing regulatory lifecycle of products. Excellent documentation, analytical, and communication skills. Ability to multitask and work collaboratively across teams. Preferred Attributes: Self-driven with a proactive approach to problem-solving. Strong attention to detail and compliance-oriented mindset. Ability to mentor junior team members

Position Title: AVP Product Management Industry- Life Insurance Key Responsibilities: The Assistant Vice President Product Management will be primarily responsible for the following areas 1. IRDAI Filing Documents: Prepare and thoroughly review all IRDAI filing documents, including: Sales literature Policy documents Proposal forms Benefit illustrations Other regulatory submissions Coordinate with cross-functional teams such as Actuarial, Compliance, Claims, and Operations to finalize documents. 2. Product Launch Management: Lead end-to-end product launch initiatives: Conduct "Train-The-Trainer" sessions to ensure sales readiness. Ensure marketing collaterals are prepared and aligned with brand standards. Manage system readiness including UAT sign-offs, product boundary validations, premium/benefit calculations, and accurate deployment of product content across digital platforms (website, app). 3. New Product Development: Drive the ideation and development of innovative product concepts aligned with customer needs, market trends, and regulatory compliance. Collaborate with internal stakeholders to take ideas from concept to commercial launch. 4. Data Analytics & Business Insights: Deliver actionable insights and dashboards to senior leadership for strategic decision-making. Analyse product and channel performance to support product mix optimization. Develop product content and storytelling materials to enhance sales and marketing effectiveness. 5. Competition Benchmarking: Monitor and analyse competitor products, pricing, features, and positioning. Share timely and detailed benchmarking insights to support strategic planning and product enhancements. If interested, kindly share your updated resume at: [HIDDEN TEXT] Show more Show less

Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional teamtowardsto meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualifications M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years

Role: Senior Manager - Actuarial Job location: Lower Parel, Mumbai Role & responsibilities: 2-3 years of experience in General Insurance, not necessarily in Indian market Understands the actuarial reserving methodologies for different lines of business Ability to follow technical instructions and work independently on various processes related to reserving including data preparation and reconciliation The role will involve other analytical work like actual vs expected analysis, preparation of audit trail, helping Head of Reserving on various regulatory submissions Good understanding of data, systems Ability to work under pressure and coordinating with other business units like Claims, Finance, IT etc. Good at Excel, knowledge of R would be preferred

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications, preparing and compiling new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards, critically reviewing documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence, collaborating with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions, ensuring effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines, and maintaining high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA). You must possess strong technical skills in data analysis and interpretation of regulatory documentation, excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach, effective negotiation and communication skills for liaising with internal teams and external agencies, proficiency in drafting and reviewing documents in line with global, regional, and national regulatory standards, expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word, strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly, demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions, collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities, and capable of delivering high-quality outputs under pressure and within aggressive timelines. You should also have the flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions. Joining this high-performing regulatory team will allow you to play a critical role in bringing impactful pharmaceutical products to patients globally in a collaborative, fast-paced environment where your expertise shapes international market access strategies.,

As the Assistant General Manager for Nasal Spray Formulation Development in the Research & Development department at the R&D Center in Chinchwad, Pune, you will be responsible for leading the development of innovative nasal spray formulations. Your role will involve steering projects from concept to commercial scale-up, focusing on designing, developing, and optimizing nasal spray drug products to ensure regulatory compliance and meet quality standards. You will be leading a team of formulation scientists and collaborating with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Your key responsibilities will include: - Developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Preparing and reviewing literature search reports for drug substances and products, and designing product development strategies based on the findings. - Planning and guiding executives for development batches in the lab, ensuring compliance with SOPs. - Providing expert input into formulation and process studies to ensure product compliance with specifications. - Ensuring formulations and processes designed at R&D scale are capable of scale-up and technical transfer to GMP facilities. - Evaluating alternate vendors for packaging material selection and monitoring stability studies. - Preparing/reviewing Technology Transfer documents and coordinating with all stakeholders within the organization. - Following Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP) and participating in stability and validation batch manufacturing. - Preparing Product Development Reports for regulatory submission and drug product approval. You should possess the following qualifications and skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or a related field, with a specialization in drug delivery systems or formulation science preferred. - 8-10 years of hands-on experience in formulation development, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Strong technical expertise in nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience in project management, working with cross-functional teams, and managing regulatory requirements. - Proven leadership abilities, excellent communication skills, and strong problem-solving capabilities. This role will require you to be primarily based at the R&D center in Pune, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,

The role of General Manager, Veterinary Sciences at Syngene International Ltd. in Bangalore is a highly strategic position responsible for leading the BBRCs in vivo research operations. As the Head of Veterinary Sciences, you will oversee a 50,000 sq. ft. AAALAC-accredited facility supporting various therapeutic and functional areas. Reporting to BMS Veterinary Sciences leadership and the Head of Site Operations, you will play a crucial role in the BBRC Operations Leadership Team. Your main responsibilities will include ensuring high-quality support for in vivo pharmacology, DMPK, toxicology, and translational research within the Veterinary Sciences BBRC function. You will collaborate with global stakeholders to align strategies across R&D sites and drive long-term strategies to develop capabilities and capacity in support of BMS drug discovery portfolio. As a leader, you will be responsible for coaching and developing a multidisciplinary team to meet departmental objectives while fostering a culture of excellence, collaboration, accountability, and continuous learning. Oversight of local aspects of veterinary care, animal welfare, and vivarium operations to ensure compliance with international regulations and BMS standards will also be part of your role. Your qualifications should include a PhD in Veterinary Science (a plus), board certification in Laboratory Animal Medicine, eligibility for veterinary licensure in India, and at least 15 years of experience in laboratory animal medicine with leadership roles in pharmaceutical or research settings. Additionally, you should have expertise across multiple species used in pharmaceutical research, strategic acumen in managing vivarium and veterinary functions, strong interpersonal and communication skills, and the ability to manage multiple projects with resilience and emotional intelligence. Preferred attributes for this role include operational leadership of multi-site or global veterinary functions, scientific innovation in developing in vivo disease models, and a passion for ethical research, leadership, and high-performing team development. Syngene International Ltd. is an equal opportunity employer committed to fostering a diverse and inclusive workplace.,

As a Manager of Biostatistics at Syneos Health, you will play a crucial role in ensuring that the Biostatistics department meets project timelines, delivers high-quality results, adheres to project requirements and SOPs, and operates within budget constraints. Your responsibilities will include participating in the development of department SOPs, overseeing staff development and training, promoting standardized processes, and facilitating succession planning. You will be responsible for setting goals for direct reports, managing their performance, identifying training needs, supporting development plans, mentoring, and coaching staff members. By actively participating in hiring, onboarding, transferring, and terminating staff, you will maintain a diverse team with the necessary skills and competencies to fulfill the department's business objectives. In addition to maintaining a good understanding of clinical drug development, regulatory guidelines, and biostatistics, you will provide mentorship within the Biostatistics department and conduct training for associates. Your role will involve prioritizing activities across projects, resolving project conflicts, assigning Biostatisticians to projects, conducting senior reviews of project deliverables, and leading or participating in multiple studies or programs. Furthermore, you may support business development activities, lead departmental or corporate initiatives, and undertake other work-related duties as assigned. Travel requirements for this role are minimal. To qualify for this position, you should hold a graduate degree in biostatistics or a related discipline and possess extensive experience in clinical trials or a relevant field. Previous management experience or demonstrated leadership abilities are preferred. A solid understanding of the drug development process, regulatory requirements, and relevant guidelines is essential, along with proficiency in English communication. Excellent interpersonal skills, including communication, presentation, and influencing abilities, are also required. At Syneos Health, we are dedicated to developing our employees, fostering a supportive and inclusive work culture, and creating a diverse and collaborative environment. Join us in our mission to accelerate customer success and make a meaningful impact in the biopharmaceutical industry. Please note that the tasks, duties, and responsibilities outlined in this job description may not be exhaustive. The Company reserves the right to assign additional tasks or responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. This job description does not constitute an employment contract and is intended to comply with all applicable laws and regulations governing employment practices.,

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You will be seen as a valuable resource within the regulatory team, working with minimum supervision but keeping senior staff informed of your progress. Your tasks will involve developing and applying a basic understanding of regulatory frameworks, requirements, legislation, processes, and procedures. You will manage projects, write reports, coordinate regulatory activities, and execute regulatory assignments that are broad in nature. Additionally, you will assist in the development and review of standard operating procedures (SOPs) and contribute to regulatory strategy updates. You will provide regulatory input for new product development and product lifecycle planning, evaluate the regulatory impact of proposed changes to launched products, and investigate the regulatory history and background related to specific classes, diseases, therapeutics, or diagnostics for regulatory assessment. Your role will also involve determining and communicating submission and approval requirements to relevant stakeholders. To qualify for this position, you must have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3-5 years of experience in a similar role within an R&D environment is preferred. Experience with post-market activities and change management will be advantageous, and holding an RAC Certification is also preferred. If you are looking to join a dynamic team where you can leverage your regulatory expertise to drive compliance and contribute to the successful launch of new products, this role may be the perfect fit for you. Apply now and be part of a team that is dedicated to ensuring regulatory excellence and innovation in the medical device industry.,

About Us: InSilicoMinds is a leader in the application of computational modeling and simulation (CM&S) for pharmaceutical research and development. We focus on harnessing cutting-edge in silico technologies to streamline drug design, formulation development, and regulatory submissions. Our innovative approaches help to accelerate drug discovery while optimizing formulations and ensuring high-quality manufacturing processes. Position Overview: We are looking for a highly skilled and motivated Computational Chemistry Expert with hands-on experience in retrosynthesis and reaction simulation. The ideal candidate will have deep expertise in computational chemistry tools and software, with a focus on optimizing reaction pathways to achieve high yields, minimal impurities, and selective production of specific isomers and polymorphs. Key Responsibilities: Lead retrosynthesis projects aimed at developing efficient synthetic routes for pharmaceutical compounds. Simulate reaction pathways and optimize reaction conditions, including solvent selection, temperature, and reagent concentrations, to maximize desired product yield. Address challenges related to regioselectivity, stereoselectivity, and polymorphism, ensuring the selective formation of specific isomers and crystalline forms. Collaborate with cross-functional teams, including synthetic chemists and formulators, to translate computational insights into experimental protocols. Utilize advanced computational chemistry tools and software to predict reaction outcomes, impurity formation, and scalability of processes. Continuously explore new computational methodologies and contribute to the development of in silico tools and workflows within the organization. Present and defend findings and strategies in project meetings, contributing to decision-making processes. Qualifications: Ph.D./ masters in computational chemistry, Organic Chemistry, or a related field, with strong knowledge of retrosynthesis and reaction mechanism modeling. Proven experience in simulating chemical reactions and optimizing reaction parameters to improve yield, reduce impurities, and control isomer or polymorph formation. Proficiency in computational chemistry software, such as Gaussian, Schrdinger, ORCA, or similar tools. Familiarity with molecular modeling techniques, including quantum chemistry, molecular dynamics, and thermodynamic simulations. Strong analytical skills and problem-solving abilities with attention to detail. Excellent communication skills and ability to work in a collaborative, interdisciplinary team environment. Preferred Experience: Experience with cheminformatics tools and databases for reaction prediction. Knowledge of AI or machine learning applications in retrosynthesis or reaction optimization. Experience in the pharmaceutical or chemical industry, especially in synthetic route design or process optimization.,

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

As a Regulatory Affairs Specialist, you will be responsible for the following tasks: Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil, and ROW market. This includes ensuring compliance with the specific requirements of each regulatory body. Handling the preparation of query responses for drug substances in both highly regulated and less regulated markets, catering to the needs of diverse customers. Creating applicant parts and closed parts for submission to different regulatory authorities on behalf of various clients. Managing the annual updates and amendments of drug master files for the US through ESG, ASMF via CESP, and KDMF via MFDS Korea to maintain regulatory compliance. Coordinating the preparation and submission of CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia) applications and responses to the European Directorate for the Quality of Medicines (EDQM) via CESP. Preparing CEP Letters of Access (LOAs) and declarations for customers and regulatory authorities as required. Conducting research to collect and evaluate scientific data for regulatory assessments and compiling the necessary documentation for submissions to authorities and clients.,

Job Summary: The Team Leader Finance - Reporting will be responsible for end-to-end financial and regulatory reporting related to GIFT City financial books of the life insurance business. This includes timely closure of Gift city books, OPEX booking, GL reconciliation, and ensuring compliance with Statutory regulations. The role involves working closely with cross-functional teams to support business performance reporting, financial control, and regulatory submissions Key Responsibilities: Prepare and file all statutory returns in line with GIFT City regulations. Ensure adherence to deadlines, completeness and compliance in regulatory submissions. Monitor and track operational expenses (OPEX). Ensure timely and accurate month-end and year-end GL closure for GIFT City operations. Perform account-level reconciliations and resolve discrepancies. Maintain accurate financial records specific to GIFT City operations. Ensure compliance with IFSC accounting guidelines and support internal/external audits. Prepare monthly MIS and variance analysis reports. Assist in budgeting, forecasting, and tracking key financial metrics. Automate repetitive reporting processes using Excel VBA or Power BI. Design and implement SOPs for routine Gift City processes and reporting. Coordinate with auditors and provide necessary schedules and documentation. Ensure adherence to internal financial controls and company policies. Collaborate with Finance, IT, Underwriting, Operations, and Compliance etc. teams. Present periodic financial and operational insights to senior management including monthly/quarterly/annual results and reasoning for the same. Skills Required: Knowledge of insurance accounting and financial reporting frameworks. Expertise in GL closure, OPEX tracking, and financial reconciliations. Proficiency in MS Excel, and financial systems (e.g., SAP, Oracle or similar ERP). Familiarity with IRDAI, SEBI, GIFT City / IFSC and SEZ regulatory requirements. Strong analytical, problem-solving, and interpersonal skills.

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

As an intern at Noccarc Robotics, your day-to-day responsibilities will involve conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. You will collaborate with intensivists, respiratory therapists, and ICU staff to assess product performance. Additionally, you will be responsible for designing and executing ex-vivo and in-clinic testing protocols to validate device functionality, accuracy, and safety. Your role will also include collecting, analyzing, and interpreting clinical data to provide insights for product improvements. You will document findings, prepare validation reports, and contribute to regulatory submissions. Identifying and troubleshooting device performance issues will be a key part of your responsibilities, as you provide feedback to the engineering and R&D teams for product refinements. Furthermore, you will assist in developing clinical workflows and best practices for the use of Noccarc devices in ICU settings. Conducting competitor benchmarking studies to ensure Noccarc's products remain at the forefront of respiratory care technology will also be part of your tasks. You will have the opportunity to contribute to articles and blogs on best clinical practices, device usage instructions, various manuals, and journals published by Noccarc. Noccarc Robotics is a rapidly growing hardware and med-tech startup in India that was co-founded by IIT Kanpur graduates. The company emerged as a leading manufacturer of ICU ventilators in India, achieving an 18-20% market share in the country. Noccarc Robotics raised its seed round from the IAN Fund in June 2019 and has been profitable since December 2020, with annual revenues exceeding $11 million. The company prides itself on its team's solution-driven, go-getter attitude, result-oriented work culture, and a talented young team comprising individuals from prestigious institutions such as IITs, IIMs, and NITs. With a workforce of 130 employees, Noccarc Robotics has witnessed exponential revenue growth over the past two years.,

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for regulatory filings. Active involvement in OOS/OOT investigations, troubleshooting, and CAPA implementation.

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y