Regulatory Affairs Executive

2 weeks ago

Navrangpura Ahmedabad Gujarat, India Bexcode Services Full time

**Regulatory Affairs Executive Job Description**

**Job Summary**:
The Regulatory Affairs Executive will work with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements.

**Duties/Responsibilities**:

- Works in the regulatory affairs department on assigned projects.
- Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
- Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
- Notifies Regulatory Affairs Manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
- Serves as a representative for the regulatory affairs department at process review meetings.
- Establishes and maintains business relationships with officials in federal and state government regulatory agencies.
- Performs other related duties as assigned.

**Required Skills/Abilities**:

- Extensive knowledge of applicable federal and state regulations and the ability to stay current on regulations.
- Should have adequate knowledge of current regulations and requirements of health Canada for natural health products
- Knowledge of preparing dossier of semi regulated countries for Dietary and Health supplement is recommended.
- Should have an intermediate knowledge of product manufacturing and quality assurance.
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills.
- Proficient with Microsoft Office Suite or similar software.

**Education and Experience**:

- Bachelors degree in Pharmacy.
- Experience of t least 1 year in the field of regulatory affairs is an asset.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹20,000.00 - ₹40,000.00 per month

Schedule:

- Monday to Friday
- Night shift

Ability to commute/relocate:

- Navrangpura, Ahmedabad - 380014, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- FDA regulations: 1 year (preferred)

**Speak with the employer**
+91 9834797634

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