Assistant Director Regulatory Affair (EU Region)

KeyResponsibilities:

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.

6. Regulatory Intelligence & Compliance:

7. Team Leadership and Mentorship: Lead and mentor a team of regulatory professionals, fostering a culture of collaboration, excellence, and continuous learning.

8. Electronic Submissions Management: Use eCTD software such as Lorenz DocuBridge for managing electronic submissions. Ensure adherence to regulatory submission guidelines across EU markets.

9. Database and Record Management: Maintain and update databases for submissions, queries, variations, and approvals. Ensure all records are accurate and easily accessible for audits and inspections.

10. Regulatory Query & Response: Handle queries efficiently to avoid delays in approvals.

Skills&Knowledge

1. Extensive experience in Regulatory Affairs for EU Market.

2. Strong knowledge of CMC (Chemistry, Manufacturing, and Controls) document review processes.

3. Experience in the DCP and Variations procedures and management end to end.

4. Experience using regulatory submission tools like Lorenz DocuBridge or other eCTD software.

5. Excellent communication skills, both written and verbal, in English. Proficiency in other languages (preferred but not required).

6. Detail-oriented, highly organized, with a strong ability to manage multiple projects and meet tight deadlines.

7. Proven track record of successful regulatory submissions and approvals in EU markets.

8. Up-to-date knowledge of global regulatory environments and trends, particularly in the EU markets.

Preferred Qualifications:

• Experience working with regulatory submissions and queries for EU markets.
• Familiarity with the latest regulatory trends and guidelines specific to emerging markets in the EU region.