Manager - Regulatory Affairs - Pharma

We have requirement for a leading Pharmaceutical organisation. Prefer candidate from Pharma Industry.

Job Description :

Designation: Manager- Regulatory Affairs (Dietary/Nutraceuticals)

Educational Qualification : B.Pharma/M.Pharma preferably with Pharmcognosy background

Job Summary:

- Lead & execute the regulatory strategy for Nutraceuticals & Dietary products for India/ROW countries. Obtaining different manufacturing permissions.

- Building & maintaining a credible relationship with FSSAI/regulatory authorities.

- Providing & review of high quality documents including CMC data, regulatory compliance, electronically transmissible Data as per the agreed timelines.

- Dossier preparation & submissions for Dietary/Food supplements and Nutraceuticals in ROW & Domestic markets as per business plan.

- Responsible for sending response to FSSAI/regulatory agencies during product registration timeframes. (Preparation of clear, accessible product labels, PIL's & artworks)

- Accountable for the timely preparation and filing of submissions, follow-up and approval of new Marketing Authorizations in line with agreed business plans.

- To ensure all regulatory submissions, correspondence and approvals are accurately communicated, recorded.

- Directly communicate with registration managers located in specific countries, international customers, respective regulatory authorities (MOH) regarding raised Registration status, Queries and Request of information (RFI) and to take follow-up from country specific registration managers (situated at particular country) about registration/reregistration status of products.

- Preparation of high quality Medical and Scientific communications including patient narratives, literature review, abstracts, product manuals, slide

sets presentations for submission to regulatory authorities.

- Development of artworks & labeling as per requirements of FSSAI/respective country.

- Preparation, Proofreading of Legal applications & Technical Documents before submission to FSSAI at Central & State level.

- Monitoring & setting timelines for license variations and renewal approvals.

Technical Skills

- Filing exposure for Indian/ ROW markets for dietary/Nutritional/food/ New launched products.

- Regulatory exposure from filings to launch

- Familiar with or knowledge in dietary supplement/ functional foods/ Herbal regulations/regulatory affairs (FSSAI,FD&C Act, DSHEA,FDA etc)

- Comprehensive Knowledge and Experience of Chemistry, Manufacturing and Control (CMC) Writing, Country Specific Dossiers, Master Files etc.

- Strong regulatory background includes knowledge of ROW & Domestic registration guidelines & regulations.

Behavioral Competencies

- Proactive & forward thinker

- Should be able to provide timely, comprehensive & robust regulatory guidance

- Should be able to forge new standards to deliver more predictable outcomes.

- Proficiency in Written & Spoken English.

- Should be capable of addressing public in Conferences & make presentations to Regulatory authorities etc.

Interested candidates can apply with their resume with following details :

Current CTC:

Expected CTC:

Notice Period:

Rohit Chavda

Anup International