Assistant Director - Regulatory Affairs - EU Region (6-15 yrs)

Key Responsibilities:

1. Regulatory Submissions & Strategy (EU Markets): Lead regulatory submissions and manage post-submission activities for EU markets. Ensure all filings and responses are compliant with applicable regulations.

2. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure timely and accurate preparation of regulatory submissions, including Clinical, Quality, and Nonclinical documents.

3. Regulatory Document Review: Lead the review and compilation of all relevant regulatory documents in line with local and international guidelines. Ensure technical arguments are clear and conclusions are adequately supported by data.

4. Labeling and Product Information: Oversee the drafting and review of labeling and product information to ensure compliance with regional regulations and company standards.

5. Change Management and Variation Filings: Track regulatory variations, ensure documentation is up-to-date, and manage approval timelines to maintain product compliance across multiple jurisdictions.