Job Description

1. Experience in Regulatory Affairs/Regulatory operations with a significant focus on EU variations filings especially for oral solid dosages in European markets and other dosage forms.

2. Preparation, execution, submission, and submission management.

3. Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalize the documents, coordinate and prepare submissions

4. Review technical reports, summary documents, and change controls (chemistry, manufacturing, and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.

5. Regular interaction with various EU Health Authorities in preparation, pre-approval and post approval management

6. Interaction with other members related to regulatory requirements, submissions, strategic decisions, and other internal conversations.

7. Hands on experience in leading a variety of Regulatory submission activities (NDA, ANDA, IND, MAs, Post Approval Supplements, PSURs, Annual Reports.)

8. Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate

9. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

10. Familiar with a variety of pharmaceutical concepts, practices, and procedures and the functioning of a regulatory affairs department.

11. Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.

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