Roles and Responsibilities
You will be responsible for,
1. Candidate will be responsible for Providing operation regulatory support to project manager on new divestment projects, technical transfer, CMOs quality assurance and commercial departments.
2. Experience in Supporting regulatory submissions in the EU, US, and ROW markets.
3. Candidate will be responsible for Producing documentation for submission, including M1 and M3 dossier sections, justification documents and product information.
4. Candidate will be responsible for Monitoring labelling compliance across multiple markets, coordinates the review of the Company Core Data sheet (CCDS) and subsequent safety updates globally.
5. Candidate will be responsible for Continual communication with local health authorities, local
consultancies, distributors, and internal stakeholders to ensure timely and accurate submissions
6. Candidate will be responsible for senior management and project strategy teams, supporting global cross functional regulatory strategies.
Desired Candidate Profile
Candidate should be Bachelors Degree in pharmacy, biology, chemistry, pharmacology and At least 10 years of related experience within a pharmaceutical company, CRO or CMO.
1. Candidate should have good experience of working with regulatory authorities and knowledge of the regulatory framework and guidelines.
2. Experience of regulatory submissions in the EU, US, and ROW markets.
3. Strong IT Skills including MS Software including, Excel, PowerPoint, and Word.
4. Experience in CCDS and SMPC updates, labelling process and artwork approval.
Perks and Benefits
5 days working week
UG:B.Sc in Any Specialization,B.Pharma in Any Specialization
PG:M.Pharma in Any Specialization,MS/M.Sc(Science) in Any Specialization
Top Pharma MNC Co.
Reference Id:Sr. Executive/ Manager Regulatory Affairs- Pharma MNC, Gujarat/ Mumbai
13,00,000 - 15,00,000 P.A.
Pharmaceutical & Life Sciences
Legal & Regulatory
Regulatory Affairs Compliance
Full Time, Permanent