Executive Regulatory Affairs
5 months ago
Key Responsibilities:
- Should have 3-5 Years of Experience in Regulatory Affairs
- Coordinate with Plant and associated departments to facilitate the dossier requirements.
- Review of PVP PVR, Stability, PDR, BMR, and other directly or indirectly linked Quality Section in CTD/ACTD
- Experience in handling markets like African Countries, the Philippines, Russia (CIS), Sri Lanka, etc are preferred.
- Preparing Dossiers, Review and Filling Dossiers.
- Registration in Semi Regulated and Regulated Markets.
- Checking Artworks of Pharmaceutical Products and performing artwork modification as per Country requirements.
- Timely answering Queries raised by Health Authorities of respective countries and customers to expedite the registration process.
- Good communication skills in client handling
- Handle regulatory activities by setting and managing work priorities and time allocation
- Review of Regulatory Documents i.e. dossiers, response to deficiencies, and guide team members.
- Coordination with the Plant for registration and other technical documents.
- DMF review
**Salary**: ₹20,000.00 - ₹25,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Health insurance
Schedule:
- Day shift
Supplemental pay types:
- Commission pay
- Performance bonus
- Yearly bonus
Ability to commute/relocate:
- Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
Work Location: In person
**Speak with the employer**
+91 8828095755
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