Regulatory Executive for Registration

5 months ago

Mumbai Maharashtra, India Double HR Consultancy Full time

Mumbai, Vile Parle East, Maharashtra Nagar

Position: Regulatory Executive
Job Location: Vile Parle Mumbai: Maharashtra

Eligibility:
M. Sc / B. Sc / M. Pharma / B. Pharma. Degree / Diploma in Regulatory Affairs
- Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries
- FDA: Registration and Post-registration activities in the Rest of the world countries (AFRICA, ASIA, Latin America, CIS, Gulf Countries, and South Asia (Afghanistan and Sri Lanka).
- Registration dossier submissions as per CTD, ACTD, and National guidelines.
- Renewal and variation submission as per countries\' guidelines.
- Submission of documents for desktop audits, and registration of the manufacturing sites.
- Involve in the budgeting
- The budget includes site inspections, registrations, and renewals.
- Involve in the yearly submission planning
- Check guidelines and feasibility to register the products in the new countries.
- Coordinate with the internal different departments to get and review the documents for compilation and submission purposes. Coordinate with the labeling team to develop new artwork.
- Having good knowledge of CTD, ICH, guidelines.
- Managing regulatory affairs of the organization & its subsidiaries / associates.
- Liaising with regulatory bodies like State and Central FDA, DCI, etc.
- Well conversant with Drug law/feed supplement regulation.
- Coordination with factory, purchase department, marketing department.
- Reviewing of technical documents like process validation, stability, etc.
- Compilation of dossiers and handling dossier-related queries.
- Arranging and checking artworks for registration as per guidelines.
- Compilation and preparation of tender documents.
- Experience- 3 - 5 Years- Salary- 4 Lac To 5 Lac P.A.- Industry- Pharma / R&D / Biotech- Qualification- Diploma, Professional Degree, B.Pharma, B.Sc, M.Pharma, M.Sc- Key Skills- Regulatory Executive Registration & Renewal of Drugs Feed Supplements Regulatory Affairs Registration RenewalAbout Company
- Contact Person- Kashinath Jha- Mobile- 9820032472

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