Regulatory Affairs

1 week ago

Surat Gujarat, India SALVAVIDAS PHARMACEUTICAL Full time

**Roles & Responsibility**:

- Prepare, compile, and submit regulatory documents to health authorities (e.g., FDA, EMA, MOH) for product approvals, renewals, and variations.
- Ensure all submissions are accurate, complete, and submitted in a timely manner.
- Ensure compliance with all local, national, and international regulations and standards for pharmaceutical products.
- Keep up-to-date with changes in regulatory guidelines and inform the relevant departments.
- Manage and oversee the registration of new products in various markets.
- Liaise with health authorities and regulatory agencies to facilitate product approvals.
- Work closely with research and development, quality assurance, manufacturing, and marketing teams to ensure that all products meet regulatory standards.
- Monitor the regulatory environment and assess the impact of new regulations on the company’s products.
- Maintain and update regulatory documentation, including technical files and product dossiers.

**Required Skills**:

- Knowledge of regulatory market
- Analytical Skills
- Time Management
- Problem-solving skills
- Attention to details
- Communication skills

Pay: Up to ₹40,000.00 per month

Schedule:

- Day shift

**Experience**:

- Regulatory Affairs: 2 years (required)

Work Location: In person

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