Sr Manager Regulatory Affairs

Manager / Sr. Manager Regulatory Affairs (US Team)

Reports To: Head – Regulatory Affairs

Market: US and EU

Location: Vadodara

Job Purpose:

To lead site transfer regulatory activities, ensuring timely compilation, review, and submission of ANDA variations, change controls, and query responses to health authorities like USFDA, EU and Health Canada.

Responsibilities:

1. Regulatory Submissions and Approvals:

Prepare Review and submit dossiers for product registrations and post approval changes in US or Europe markets, ensuring adherence to country-specific guidelines and requirements.

Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions.

Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies.

2. Compliance and Documentation:

Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations).

Maintain accurate and up-to-date records of regulatory documents, approvals, and communication.

Monitor and ensure compliance with post-marketing regulatory requirements such as periodic updates, renewals and reporting obligations.

3. Labeling and Packaging Compliance:

Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions.

Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities.

4. Product Development Support:

Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development.

Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies.

5. Regulatory Intelligence:

Stay updated on changes in regulations, guidelines, and standards in the Europe, US, UK, Canada, Australia, Brazil regions.

Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations.

6. Communication and Coordination:

Act as a point of contact between the company and regulatory bodies in the assigned markets.

Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches.

7. Cross-functional Collaboration:

Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing.

Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information.

8. Product Registration Lifecycle Management:

Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments.

Ensure timely submission of regulatory documents to maintain product approvals and licenses.

9. Risk Management and Problem-Solving:

Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products.

Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions.

Additional Responsibilities:

• Review documents, identify gaps, and guide team members on remediation.
• Communicate with partners and regulatory agencies for clarification and status updates.
• Manage timelines, risk mitigation, and submission tracking.
• Train and mentor junior team members.

Qualifications:

• M. Pharm with 8–12 years in US/EU regulatory affairs.
• Strong understanding of CMC, change control, and Module 3.
• Experience in pre and/or post-approval submissions and site transfers.