Regulatory Affairs Executive
1 week ago
Mumbai, Dombivali East
Urgent Requirement
EXECUTIVE /MANAGER
REGULATORY AFFAIRS
With finish formulation experience.
Jobs Location: Dombivli (Thane) Maharashtra)
Position Title: Executive Regulatory Affairs
Industry Type: Pharmaceuticals/ Biotech
Employment Status: Permanent
Roles and Responsibilities
- New Registrations: Dossier Preparation Submission of dossiers either in the form of ACTD/CTD/
- eCTD/regional formats as per the scheduled annual grid in ROW Markets.
- Adopting the following process of:
- Communication, procurement, review, compiling, and sharing of documents,
- compliance, maintenance of additional data & backup.
- Arranging of administrative documents for manufacturing facility products
- (Manufacturing Lic, WHO-GMP, COPPs/FSC- Procuring and legalization), Samples, WS etc,
- CDPs, artworks for complete ROW markets to facilitate filings as per the scheduled grids.
- Coordination and follow-up with internal team and external agency for document process.
- Preparing dossiers as per the CTD/ country-specific requirement, Submitting dossiers to different
- countries and Confirming that these dossiers are filed in the respective countries.
- Submission of Re-registration Dossiers in ROW markets.
- Submission of Query Responses raised by the health authority in a specific timeframe. Regulatory
- Support with respect to providing the information for the facilitation of GMP inspection from various
- Health Authorities.
- Maintain Database for registration status, deficiency states, amendments (if any) and
- registration certificate. Review and approve exhibit batch /DGFT artworks.
- Arrangements of Administrative Documents Samples (FP/API) required for registration purposes
- in ROW markets.
- Release of Registration Profile, Review and approval of change controls.
- Market - Rest of World
- Education Required
- B. PHARMA in Pharmacy & PHARMA in Pharmacy
- Experience Required
- Minimum 3 and more years of experience
- Experience- 3 - 5 Years- Salary- 2 Lac 50 Thousand To 4 Lac P.A.- Industry- Pharma / R&D / Biotech- Key Skills- Regulatory Affairs ExecutiveAbout Company
- Contact Person- Kashinath Jha- Address- B 202, Bhavani Enclave Opp. Anand Old Age Home, New Satpati Road, Shirgaon, Palghar West- Mobile +91-XXXXXXXXXX
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