Regulatory Affairs Executive

Responsibilities and Duties:
- CTD & ACTD dossier preparation, review and their timely submission for ASEAN, African countries, Latin America etc.- Co-ordination with plant / QA / R&D / QC for timely catering to documents / sample requirements for regulatory submissions- Review & archival of data- Review Artwork and Label as per respective country guidelines.- Regular interaction with customers & MOH Board for Dossiers & Sample.- Queries response to clients- Follow up on Registration & Renewal status.- Retention Sample Management for Product Registration.- To review and keep samples in records.- Proper filling of documents related to DRA in HO.- To Check all the proofing of the commercial artwork received from purchase team.

- Self-Development: Reading regulatory guidelines, participating and delivering presentations.

- Lifecycle Management of approved drug products: Timely preparation and submission of annual reports/renewals. Evaluation, preparation and submission of changes through variations, supplements etc. that impact product supplies

- Regulatory Compliance- Ensure timely implementation of regulatory decisions for change management and other activities in DF plants.

Qualifications: B Pharm / M Pharm

Experience: Minimum 3-7 years’ experience

Job Type: Full-time

Pay: ₹100,000.00 - ₹300,000.00 per year

Ability to commute/relocate:

• Andheri East, Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• total work: 1 year (Preferred)

Location:

• Andheri East, Mumbai, Maharashtra (Preferred)

Work Location: In person