Regulatory Affairs Manager

1. Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.

2. Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

3. Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.

4. Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.

5. Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.

6. Conduct risk assessments and develop mitigation strategies to manage regulatory risks.

7. Monitor and track regulatory compliance metrics and provide regular reports to senior management.

8. Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

Regulatory Affairs Manager Required Skills & Experience

1. Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.

2. Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage.

3. Exceptional attention to detail and ability to review and interpret technical documentation, scientific data, and regulatory guidelines accurately.

4. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to both technical and non-technical stakeholders.

5. Strong project management skills and the ability to prioritize and manage multiple projects simultaneously.

6. Proficient in using regulatory databases and software applications to track and manage regulatory submissions and documents.

7. Strong analytical and problem-solving skills, with the ability to identify and resolve regulatory issues effectively.

8. Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels.

9. Experience in interacting with regulatory authorities and managing regulatory inspections and audits.

10. Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.

Educational Qualification

B. Pharm with 8-12 years of experience in API regulatory affairs

M. Pharm with 5-8 years of experience in API regulatory affairs

Job Type: Full-time

Pay: ₹40,000.00 - ₹80,000.00 per month

Work Location: In person