Piramal Molecular Biology Executive Job – Regulatory Affairs Vacancy, Apply Online
Executive Regulatory Affairs
Company: Piramal
Location: Mumbai, Maharashtra, India
Job Description:
The incumbent will be responsible for reviewing and finalizing regulatory documents, providing regulatory documents to institutional and ecommerce team, compiling and submitting regulatory dossier to export team, preliminary review of artworks and promotional material, understanding and staying up to date with all relevant regulations, maintaining a repository of regulatory and scientific documents, follow all departmental SOPs.
Key Stakeholder:
Internal: Marketing, Supply Chain, Quality Assurance, R&D, Sales, Business Development
External: Corporate Regulatory, Corporate Legal
Reporting Structure: Chief Manager – Medical and Regulatory Affairs
Qualifications:
- MSc (Life Science/ Biology/ Biochem/ Molecular Biology) with 3 years of experience
OR - BSc (Life-Sciences/ Biochem /Biotech)/BPharm with at least 5 years of experience
Experience:
- 2-5 years of experience
- Well-versed with regulations such as FSSAI, D&C Act, DMR Act, BIS, Legal Metrology
- Has a good understanding of the operational processes of FSSAI, DCGI and other regulatory bodies
- Previous regulatory experience in drugs and/or nutraceutical
- Ability to critically review manufacturing, pharmacology, pre-clinical and clinical data, reports, literature, and documentation
Responsibilities:
Regulations and Compliance:
- Execute tasks as per SOP and work process
- Read and understand all regulatory requirements as per business needs
- Stay updated on new regulations
- Liaise with internal stakeholders to ensure OTIF delivery of projects
Regulatory Review:
- Review documents for regulatory compliance
- Conduct review of artworks of assigned products
- Conduct review of labels, pack inserts, promotional material – banners, leaflets, print ads, TVC, social media campaigns of assigned products
- Support marketing in evaluating NPDs of assigned projects
Exports, Institutional Sales & Ecommerce:
- Search, read and understand regulatory requirements of export markets
- Prepare product dossiers for registration
- Provide all regulatory documents in a timely manner
- Archive all submissions
- Update and maintain the status of regulatory filings
- Ensure regulatory compliance in export markets post-registration
Documentation:
- Maintain a repository of regulatory and scientific documents
- Maintain a tracker for trademarks, artworks, promotional material, exports, institutional sales
- Archive all regulatory correspondence
Other Skills:
- Interact and maintain relations with a cross-functional team
- Ability to independently manage assigned tasks
- Basic IT knowledge
Qualifications:
- MSc (Life Science/ Biology/ Biochem/ Molecular Biology)
OR - BSc (Life-Sciences/ Biochem /Biotech)/BPharm
Keywords: Executive Regulatory Affairs, Regulatory Affairs, MSc Mol Bio, Biology, Biochem, Life Sciences, Mumbai, Maharashtra, India, Regulatory Compliance. Piramal Molecular Biology Executive Job – Regulatory Affairs Vacancy, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
