Regulatory Executive for Registration

6 months ago

Mumbai, India Double HR Consultancy Full time

Mumbai, Vile Parle East
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Position: Regulatory Executive
Job Location: Vile Parle Mumbai: Maharashtra
Eligibility:
M. Sc / B. Sc / M. Pharm / B. Pharm. 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- Corporate Planning & Strategy / Management Consulting- Qualification- Diploma, Professional Degree, B.Pharma, B.Sc, M.Pharma, M.Sc- Key Skills- Regulatory Executive for Registration & Renewal of Drugs & Feed SupplementsAbout Company
- Contact Person- Kashinath Jha- Address- B 202, Bhavani Enclave Opp. Anand Old Age Home, New Satpati Road, Shirgaon, Palghar West- Mobile- 9820032472

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