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Job openings for regulatory executive in vile parle east mumbai maharashtra nagar mumbai

Regulatory Executive For Registration & Renewal Of Drugs & Feed Supplements

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 Renewal

About Company

Contact Person Kashinath Jha
Mobile 9820032472
Email ID

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