Jobs
Interviews

40 Row Market Jobs

Setup a job Alert
JobPe aggregates results for easy application access, but you actually apply on the job portal directly.

4.0 - 9.0 years

5 - 14 Lacs

Pune

Work from Office

Looking for International Business / Sales / BD / EXPORT Manager / Sr Manager for PHARMACEUTICALS EXPORTS. (B2B) Person will be responsible for Export / International Marketing / Sales for Pharma Formulation for EU, ROW Markets. Various Countries Location-Pune Corporate Office (S. B. ROAD - SHIVAJI NAGAR, PUNE ). This is a Office Based Job (Pune), Profile : Handle Current Export Business Clients smoothly Co-ordination with client and factory for timely delivery of goods.Coordinate with Regulatory Department to ensure proper dossier submission and getting MA. Required Candidate profile Good Communications Skills Honest, Hard Working Growth Mindset (Important) Ambitious & Positive Thinker 5-12 years of experience in Pharma Formulation Exports. Proficient English Writing / Speaking (Mandatory) Computer proficiency in MS Office, Excel, e-mail and internet functions PLEASE APPLY WITH PROPER COVERING NOTE at info@vekocare.com . We are fastest growing company in India, & have vacancies across different areas in Pharmaceutical Manufacturing / Sales operation. Even Junior Candidates with relevant exposure can contact us .

Posted 4 days ago

Apply

2.0 - 6.0 years

4 - 6 Lacs

Vadodara

Work from Office

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.

Posted 4 days ago

Apply

11.0 - 17.0 years

9 - 13 Lacs

Ahmedabad

Work from Office

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

Posted 4 days ago

Apply

7.0 - 12.0 years

6 - 8 Lacs

Ahmedabad

Work from Office

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. .

Posted 4 days ago

Apply

3.0 - 8.0 years

3 - 8 Lacs

Nalagarh

Work from Office

Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consultants and agents for submissions and queries. Product Lifecycle Management: Manage variations, renewals, query responses, and product registration maintenance. Handle change control and post-approval regulatory activities. Document Control: Maintain updated regulatory records and submission trackers. Ensure timely and organized archiving of all submitted dossiers and correspondence.

Posted 4 days ago

Apply

6.0 - 11.0 years

7 - 17 Lacs

Mumbai

Work from Office

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Posted 6 days ago

Apply

12.0 - 20.0 years

20 - 35 Lacs

Dholka

Work from Office

Role & responsibilities •Liaison with regulatory authorities/government bodies, coordination with customers/consultants - DGCI and India Regulatory bodies •Provide regulatory advice to cross functional departments right from the development stage leading to a scientifically sound regulatory submission within committed project timelines •Provide regulatory inputs and frame up strategy of regulatory submission during business development discussions with international customers and International Marketing Division •Guidance to regulatory/quality team to perform their respective functions efficiently and accurately. Identify team member's capabilities to perform and assign additional responsibilities accordingly. Adopt the role of a mentor to team members both personally and professionally. •Facilitate in preparing compliance to GMP audit observations for own facilities •Guide cross functional departments on implementation of systems for regulatory expectations and compliance •Review of technical and investigation reports, summaries for adherence to regulatory guidelines and to provide guidance to cross functional technical teams for the requirement and content of regulatory documentation •Evaluation of Day to Day operational issues w.r.t regulatory implications and providing short term and long term mitigation measures Preferred candidate profile Must have experience in pharmaceuticals

Posted 1 week ago

Apply

2.0 - 4.0 years

0 - 0 Lacs

Hyderabad

Work from Office

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Posted 1 week ago

Apply

4.0 - 5.0 years

2 - 3 Lacs

Panvel, Navi Mumbai, Mumbai (All Areas)

Work from Office

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

Posted 1 week ago

Apply

3.0 - 8.0 years

4 - 8 Lacs

Navi Mumbai

Work from Office

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must have exposure to in-licensed dossier filing and out licensing

Posted 1 week ago

Apply

8.0 - 12.0 years

10 - 13 Lacs

Ahmedabad

Work from Office

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

Posted 1 week ago

Apply

2.0 - 6.0 years

0 Lacs

gujarat

On-site

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.,

Posted 2 weeks ago

Apply

3.0 - 5.0 years

2 - 5 Lacs

Akola

Work from Office

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents

Posted 2 weeks ago

Apply

6.0 - 10.0 years

7 - 8 Lacs

Goregaon, Mumbai (All Areas)

Work from Office

Preparation of dossiers for semi-regulated & non-regulated markets. Responding to queries raised by the Ministry of Health (MOH) & buyers regarding dossiers. Coordinating the dispatch of samples(working standards & finished products) for registration Required Candidate profile Collecting documents required for tenders & completing relevant questionnaires. Liaising with plants & internal departments to gather necessary documents and samples, Supporting the Sectional Head.

Posted 3 weeks ago

Apply

15.0 - 22.0 years

25 - 27 Lacs

Patiala, Delhi / NCR

Work from Office

Hello Applicants We are hiring for Senior Manager API International Market (ROW Market) - Pharma API Industry - Punjab Qualification: Any Graduate and PG Marketing Experience: 15 years Location: Patiala, Delhi experience required in International Market Job Description: experience required in LATAM, MENA, APAC & ROW Market...etc...for the API interested candidates can share their cv to hr3@sarthee.com or call at 9033033650

Posted 3 weeks ago

Apply

10.0 - 15.0 years

7 - 8 Lacs

Mumbai

Work from Office

To prepare the Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dossiers for allotted countries Timely answering the queries EXP in ROW market B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

Posted 3 weeks ago

Apply

2.0 - 5.0 years

3 - 6 Lacs

Mumbai

Work from Office

RESPONSIBILITIES Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets. Coordination with the customer at various registration stages to obtain approval. Analyze the molecule and determination for need of Bioequivalence or bio waiver studies. Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients. Review and approve the artworks as per Brazil and Canada market regulations. Interpretate deficiencies received compile and submission responses within the stipulated time frame. Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines. DESIRED SKILLS Good knowledge of Registration requirements in ROW market. Experience in submission of generic medicine dossiers to the ROW market. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets. Good analytical and problem-solving skills. Ability to try new approaches when faced with challenges. Should have a good analytical and learning attitude. Proactive to submission of response to any queries. Good communication skills.

Posted 4 weeks ago

Apply

5.0 - 10.0 years

5 - 15 Lacs

Chennai

Work from Office

We are looking for a dynamic and experienced professional to lead API sales and business development in the Indian market and support growth in APAC and MENA regions . The ideal candidate will have strong industry relationships, a solid understanding of generic APIs , and exposure to regulatory processes . Key Responsibilities: Drive sales growth in the domestic API market Manage customer relationships with distributors and formulation companies Identify new business and product opportunities Support regulatory filings and product registration Conduct market research and competitor analysis Represent the company in client meetings and industry events If you are interested, Kindly share your updated CV to mounika.r.bvr@gmail.com

Posted 1 month ago

Apply

7.0 - 12.0 years

12 - 18 Lacs

Navi Mumbai

Work from Office

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.

Posted 1 month ago

Apply

1.0 - 4.0 years

3 - 6 Lacs

Hyderabad

Work from Office

Role & responsibilities Responsible for driving Business development for all ROW and Institutional tender business with end-to-end tender management responsibilities Identify collaboration opportunities, Analysing markets and appointing distributers in the assigned territory Tender Participation in UNICEF/PAHO/WHO/IDA and other institutional agencies Tender management- tender preparation / documentation accuracy / timely submission of EOIs, RFP’s and RFQ’s. Coordination with Alliance Management/ Regulatory / IP/ production teams for supply and documentation related needs Stock planning and inventory management in co-ordination with internal teams Ensuring OTIF (on time in full) delivery and documentation accuracy for tenders. Market research / sales data analysis/ analysing various tender related data sets to understand market trends and identifying the new portfolio opportunities for the organisation. Participate in stakeholder engagement meetings and weekly BRM’s. Visit trade fairs and countries as and when necessary

Posted 1 month ago

Apply

5.0 - 10.0 years

6 - 14 Lacs

Chennai

Work from Office

1. Identify and develop new business opportunities across LATAM markets for contract manuf. of OSD products & ointments 2.Maintain strong relationships with local distributors, pharma companies, & regulatory consultants 3. Lead product registrations Required Candidate profile 1.Must have 5+ years in pharma BD, focused on LATAM 2.Knowledge of LATAM regulatory bodies (ANVISA, INVIMA) 3.Exp in OSD manufacturing business 4. Spanish/Portuguese language skills are a plus!

Posted 1 month ago

Apply

2.0 - 4.0 years

8 - 12 Lacs

Pune

Work from Office

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Posted 1 month ago

Apply

8.0 - 13.0 years

7 - 16 Lacs

Hyderabad

Work from Office

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 08 to 13 years of experience in FML Regulatory Affairs Job Title : Asst. Manager / Deputy Manager / Manager / Sr Manager Experience : 08 to 13 years in FML RA field Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Roles & Responsibilities : Collect documents from various departments to prepare regulatory submissions. Prepare regulatory submissions to relevant authorities. Prepare amendments, updates, and revisions to submissions. Conduct meetings with cross-functional teams (CFT) to address deficiencies received from regulatory authorities and customers. Draft responses to regulatory deficiencies and review comments. Update the database as per requirements. Prepare the applicant and restricted parts for Abbreviated New Drug Applications (ANDAs). Compile dossiers in electronic Common Technical Document (eCTD) and Common Technical Document (CTD) formats for all relevant countries. Guide the CFT based on current requirements from regulatory authorities. Plan and allocate projects within the team. Assess proposed changes for approved products and finalize the submission category. Review and clear specifications, protocols, stability data, bio-waivers, etc. Key Performance Indicators: Demonstrate in-depth knowledge of regulatory guidelines and requirements for each market. Ensure all submissions are cleared within the stipulated timeline. Provide actionable items to address regulatory queries and dossiers. Required skills : Knowledge of RA Guidelines and Requirements Action Item for RA deficiency. Cross-Functional Team Work Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities Support plant teams in regulatory audits, liaison with domestic & export regulatory authority. Assess and approve change controls and update files accordingly Interview Date : 27-05-2025 Department : Regulatory Affairs - FML Dept. Experience : 08 to 13 Years Position: Asst. Manager / Deputy Manager / Manager / Sr Manager Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025.

Posted 1 month ago

Apply

5.0 - 10.0 years

5 - 10 Lacs

Pune

Work from Office

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Markets, LATAM, ROW International @ 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.

Posted 1 month ago

Apply

1.0 - 5.0 years

2 - 4 Lacs

Ahmedabad

Work from Office

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

Posted 1 month ago

Apply
Page 1 of 2
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Featured Companies