Regulatory Affairs Manager - Pharma

Key Responsibilities:

Exp 8+ Years

- Lead the preparation, submission, and management of regulatory filings for product approvals.

- Ensure compliance with local, national, and international regulations (FDA, EMA, etc.).

- Monitor regulatory changes and update the company's practices accordingly.

- Collaborate with R&D, QA, and other departments to ensure regulatory compliance during product development.

- Maintain regulatory documents and keep accurate records of approvals and licenses.

- Provide regulatory guidance and support during audits and inspections.

- Develop strategies for new market entry and regulatory approvals

- Communicate with regulatory authorities to resolve issues and gain product approvals.

Qualifications :

- In-depth knowledge of regulatory requirements and industry standards.

- Strong communication and project management skills.

- Degree in pharmacy, life sciences, or a related field.

- Experience in regulatory affairs, preferably in the pharmaceutical industry.