Regulatory Affairs Executive
3 months ago
**Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post.
Qualification
- B.Pharm/ M. Pharm
Experience
- 3+ years of experience in regulatory affairs for ROW market (Rest of the world)
**Job Summary**:
The Regulatory Affairs Officer ensures that a company's products comply with all relevant regulations and standards in domestic and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance throughout product development, and acting as a liaison with regulatory agencies.
**Key Responsibilities**:
- Prepare and submit regulatory dossiers to health authorities.
- Ensure product compliance with regulations across markets.
- Monitor regulatory changes and assess their impact on products.
- Review product labeling and promotional materials for compliance.
- Liaise with regulatory bodies (e.g., FDA, EMA, CDSCO) and handle product registrations.
- Provide regulatory guidance to internal teams.
- Manage regulatory documentation and records.
**Key Skills**:
- Strong knowledge of regulatory guidelines (FDA, EMA, etc.).
- Excellent communication and attention to detail.
- Ability to manage multiple projects and meet deadlines.
**Job Types**: Full-time, Permanent
Pay: ₹30,000.00 - ₹40,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Leave encashment
- Paid time off
- Provident Fund
Schedule:
- Day shift
- Fixed shift
Ability to commute/relocate:
- Vasna Road, Vadodara, Gujarat: Reliably commute or willing to relocate with an employer-provided relocation package (preferred)
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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