Regulatory Affairs Executive

3 days ago

Vasna Road Vadodara Gujarat, India Vega Biotec Pvt. Ltd Full time

**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: ₹11,199.45 - ₹40,000.00 per month

**Benefits**:

- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift
- Fixed shift

Supplemental Pay:

- Yearly bonus

**Education**:

- Bachelor's (required)

**Experience**:

- FDA regulations: 1 year (required)
- Regulatory reporting: 1 year (preferred)
- total work: 2 years (required)

**Location**:

- Vasna Road, Vadodara, Gujarat (preferred)

Work Location: In person

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