15 Regulated Market Jobs

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

As a Formulation and Development Officer for our client based in Vatva, Gujarat, you will be responsible for various key tasks. Your primary duty will involve the development of formulations for all dosage forms such as tablets, capsules, ointments, creams, gels, oral liquids, injectables, and novel drug delivery systems for different markets including regulated, domestic, and ROW markets. This includes activities like document review, planning, and conducting stability studies of R&D batches. Additionally, you will be required to provide technical support for the scale-up and technology transfer to manufacturing processes. You will play a crucial role in troubleshooting formulation-related issues that may arise during production, ensuring a smooth manufacturing process. To qualify for this position, you should hold a Bachelors or Masters degree in Pharmacy. If you believe you possess the necessary qualifications and skills for this role, we encourage you to share your updated CV with us. We look forward to reviewing your application and will reach out to you promptly.,

Looking candidates for PDR (Formulation & Development ) Dept. 5-10 years of relevant experience in solid oral dosage (Regulated Market US & Europe) Roles and Responsibilities 1.Candidate should perform literature search 2.Pre formulation development Required Candidate profile 1.knowledge of documents – Master formula card, Bill of Material, stability protocol 2.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

Designation : AGM / DGM - Formulation & Development. Qualification : M. Pharma / PhD. Experience : 15 to 20 yrs of experience in Formulation & development of Ophthalmic / Liquid oral dosage form for Regulated Market. Must have filed 10-15 products for US/EU market. Team handling,

Role & responsibilities Strategizing the Biosimilar process development based on CHO & other mammalian cells lines for developing non-infringing Upstream process. Understanding the cell Lines, cell culture & Bioreactor process based biotherapeutic proteins development towards submission in India & various regulated countries. Good knowledge of Cell line development & cell line characterization. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Designing and conducting the process characterization for upstream development Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analysing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. Capable of leading a team of Scientist & Sr. Scientist for day-to-day Cell culture works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Oversee and coordinate work performance at Production plant or any 3rd party Manufacturing unit Support to commercialization activities (assistance for tech transfer, process validation studies, manufacturing investigation, trend evaluation & troubleshooting) Literature survey, Patents identification & writing research papers Preparing CMC data package, URS, Qualifications, Process development report, BMR & implementation of Quality system. Engaging himself / herself in frequent scientific discussions, constant learner & responsible for targeted deliverables. Preferred candidate profile Candidate should be well versed with latest developments in Upstream related Instruments, Cell culture & Bioreactor process for implementing techniques towards developing the robust process in time bound manner. The candidate should be a very good team player and comfortably connect inter & intra departmental teammates with an expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. A clear and convincing oral and written communication in English is desired. He / She should have the good working knowledge of MS office, handling statistical software and related analytical tools. Principal Scientist, preferably PhD /post docs from abroad having Bioprocess cell culture experience.

Department: R&D Biotech (Downstream Process) at Airoli, Navi Mumbai Role: Downstream Process & Formulation development Opportunity: This role provides an opportunity to learn and grow to an advance level of expert in the field of downstream processing & formulation development of Recombinant Biotherapeutics Proteins. Role & responsibilities Development of non-infringing downstream purification process for cell culture based biotherapeutic proteins towards submission in India & various regulated countries. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Responsible for end-to-end process optimization of all purification unit operations viz. chromatography (Affinity, IEX, HIC, etc.), UF/DF TFF, Nanofiltration, etc. towards optimization of overall DSP process. Should carry out troubleshooting in least possible time. Fine execution of day-to-day purification works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Responsible for Scale up and technology transfer along with manufacturing support during troubleshooting at mfg. site. If required, ensuring the physical presence at manufacturing site during critical scale up/GMP batches like clinical batch, engineering batch, PV batches, etc. Regular biweekly updates to vertical heads with conclusion of performed experiments and way ahead. Align the overall development work, experiments with project deliverable timelines and company goals. Empower the team with frequent scientific discussions and energizing them for more productive outcome. Preferred candidates Candidate should be a good team player and comfortably connect inter & intra departmental teammates with expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. Strong communication Candidate should be well versed with latest developments in purification techniques and look forward for implementing them in process. Should be expert in handling and troubleshooting of DSP related instruments including purification systems, TFF systems, Nanofiltration, etc.

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Africa and Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

Role & responsibilities Senior Manager Drug Regulatory Affairs will lead regulatory strategy and operations for injectable pharmaceutical products targeted at regulated markets ( EU, Canada, Australia). This role is responsible for managing end-to-end regulatory submissions. Ensuring compliance with regional requirements, and coordinating with cross-functional teams including R&D, Quality, Manufacturing, and external partners to support product development and lifecycle management. Key Responsibilities: 1. Regulatory Strategy & Submissions: Develop and implement regulatory strategies for the injectable products for regulated markets. Oversee preparation, review, and submission of high-quality dossiers including ANDA, NDA, MAA, amendments, supplements, and annual reports. Ensure compliance with current regulations, guidance documents, and agency expectations. 2. Cross-Functional Coordination: Collaborate with formulation development, analytical, manufacturing, QA/QC, and project management teams to ensure timely and accurate compilation of regulatory documents. Provide regulatory inputs during development to ensure CMC data meet global submission requirements. 3. Communication with Regulatory Authorities: Act as a point of contact with regulatory agencies. Handle agency queries, deficiency letters, and pre-approval inspections (PAI) related documentation. Prepare teams for regulatory inspections; coordinate responses and corrective actions as required. 4. Lifecycle Management: Manage post-approval changes (CMC variations, labeling updates, product renewals). Maintain up-to-date regulatory documentation and ensure timely filing of amendments/supplements. 5. Team Leadership & Training: Mentor and supervise junior regulatory staff, providing guidance on dossier preparation and regulatory compliance. Foster a culture of continuous improvement and regulatory excellence. 6. Intelligence & Compliance: Monitor changes in regulatory guidelines and assess impact on current and future submissions. Ensure company-wide awareness of key regulatory updates and provide strategic advice accordingly. Preferred candidate profile 10+ years of relevant experience in regulatory affairs with a strong focus on injectable products. Proven track record of handling regulatory submissions and approvals in US, EU, and other regulated markets.

Role & responsibilities 1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation. 2. Application of NOC, Test License, Manufacturing and Import License 3. Reference product Characterization, Manufacturing and Import License. 4. Reference product Characterization, Reverse Engineering and prototype development. 5. Preformulation study, Manufacturing of bench scale trials for formulation development. 6. Manufacturing of process optimization batches, scale up batches and submission batches. 7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches. 8. Preparation of Product development Report for regulatory filing of products. 9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada). 10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products. 11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor. 12. Knowledge on IR/MR solid oral drug products. Preferred candidate profile Male candidate only

Greetings from Encube Ethicals Pvt. Ltd. We are looking for Sr. Manager Business Development Please find below brief details of the Company profiles and job description for your reference. Key Deliverables Identifying new BD leads for CDMO Business. RFQ preparation Contract negotiation Market research and portfolio review Costing & Business case preparation Communication with internal & external stakeholders Presentations for MIS and Business review Customer Management Cost analysis and change order preparation Project Tracking Skills Required Excellent communication skills, relationship management with internal & external stakeholders Understanding of drug development, regulatory processes and market trends Ability to manage partnerships, alliances and collaborations Comfortable using tools like Excel, PowerPoint, for data driven decision making, analytical thinking Analytical skills, Familiarity with databases for business intelligence Ability to forecast sales and assess market entry risks Critical thinking to evaluate opportunities from commercial and technical perspective.

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

Role & responsibilities 1. Responsible to lead a team of 4-5 scientist for the development of drug products of Regulated Market (EU and UK) 2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing. 3. Conduct Literature survey and compile the scientific data per product. Development of Rubust, bioequivalent formulation and processes through optimization by applying QbD principles. 4. Compilation and review of developmental data and exhibit batch stability data. 5. Should have good understanding on Reference Product Characterization, reverse Engineering, Bioequivalent Prototype development, Stability studies, Scale up activities. 6. Coordination with different cross functional team like ADL, IP, Project Management, SCM, Clinical and regulatory for smooth execution of the projects. 7. Execution of Tech Transfer and monitoring scale up / Exhibit batches. 8. Having well verse knowledge on Regulatory Guidelines for EU, Canada and TGA 9. Lab activities and team management experience is must. Preferred candidate profile Team Management, Formulation Development, Scale Up and Technology Transfer

1. Business Development Specialist - Pharma (Global Regulated Markets) Identify, assess, and pursue new business opportunities (in-licensing, out-licensing, strategic alliances) for pharmaceutical products. Collaborate cross-functionally with R&D, Regulatory, Legal, and Commercial teams. Strong understanding of pharma regulatory pathways and market access. 2. Regulatory Affairs (Both Regulated and Non-Regulated Market) : Develop and implement comprehensive regulatory strategies for new product development, lifecycle management, and post-market activities for various pharmaceutical dosage forms (e.g., tablets, capsules, injectables).

Good understanding on formulation & Development for regulated market/Should have experience on product technology transfer at plant side/ Knowledge on QBD,Good documentation practice/literature survey/ICH guidelines/ Solid Oral/Injectables/ OSD Required Candidate profile Execution of process evaluation, optimization, scale-up and exhibit batches. Meeting product development timelines/ Solid Oral/ Injectable Candidate can share their CV on stuti.naik@enaltec.com