Executive Drug Regulatory Affairs
6 days ago
**EXECUTIVE DRUG REGULATORY AFFAIRS (PHARMA-FORMULATIONS)**
Job Responsibility
- Preparation and submission of dossiers as per countries assigned.
- To handle inquiries from Regulatory Authorities related to company and product
registration.
- Submission of Registration Dossiers in EU, Semi-Regulatory and Emerging market.
- FDA related work
- Application of COPP, Legalization of Documents through different
- embassies.
- Co-ordinate with departments, Manufacturing, Product Development, QA/QC, R&D,
- Legal, Purchase etc. to ensure availability of documents and samples for submission.
- To check, review and prepare Artworks, Labels, and Pack-inserts in co-ordination with
- Art department and printers for domestic and international markets.
- To verify for completes of documents such as Process Validation, Product development
- records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers.
- Response of queries and other requirements as required by respective regulatory
- authorities in a stipulated timeframe.
- To prepare CTD & ACTD dossier. (Southeast Asia, Middle East countries)
CTC:
- 4 to 4.5 Lakhs
M.Sc / M.Pharm /B.Pharm /B.Sc Graduates with 4-7 years experience in Drug Regulatory Affairs with a Pharmaceutical Company manufacturing solid dosage forms, who are residents of Mumbai / Navi Mumbai / Thane, who can commute to Mulund comfortably may apply.
**Salary**: ₹30,000.00 - ₹45,000.00 per month
**Benefits**:
- Health insurance
Schedule:
- Monday to Friday
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Mumbai - 400080, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (required)
**Experience**:
- Regulatory Affairs: 4 years (required)
- total work: 4 years (required)
**Speak with the employer**
+91 9820556461
- Health insurance
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