Responsible for independent management of projects relating to investigation and marketing approval applications in the U.S. and ex-U.S. Provide regulatory support for chemistry, manufacturing and control, non-clinical animal studies, and human clinical studies of major projects from Phase 0 through Phase 4 commitments. Provide recommendations to project teams and Pharmacyclics management on regulatory strategy. Implement regulatory strategies and track progress towards regulatory goals. Facilitate interactions with US and ex-US regulatory bodies. Organize submissions to health authorities, including IND amendments, safety reports, pre-meeting packages, INDs, and NDA post-approval submissions. A primary focus of this position will be preparation of NDA and sNDAs for our drug candidate ibrutinib.
Key Accountabilities/Core Job Responsibilities:
- Develop regulatory strategy for products in order to optimize label and obtain shortest time to approval by regulatory agencies.
- Manage and supervise Regulatory Managers and Regulatory Associates
- Participate at the project team level, providing regulatory advice and opinion in the context of issues surrounding new product development and ongoing product support.
- Initiate and update regulatory strategic plans for assigned projects.
- Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio, including current and emerging global guidelines and regulations, relevant regulatory approaches and actions; and status of competitor products.
- Ensure project team objectives and timelines are supported with regulatory deliverables.
- Keep abreast of all pertinent laws, regulations and guidance as they pertain to regulatory strategies and submissions.
- Manage the preparation of original INDs, CTAs, NDAs, MAAs and corresponding international registration packages; and amendments/supplements to these applications and responses to regulatory agency questions, and export applications.
- Manage the preparation of health authority meeting packages and minutes of the meetings.
- Manage in conjunction with medical writing the creation of documents especially Clinical Study Reports used in regulatory submissions.
- Facilitate the preparation of documents for electronic submissions.
- Specialized knowledge of regulatory activities including but not limited to submissions to health authorities of NDA, sNDA and post-approval submissions
Education Requirements (degree, certifications, etc.):
- 6+ years regulatory affairs experience
- Prior experience with oncology/hematology and/or prior work in clinical development a big plus
- MS or PhD, PharmD or equivalent graduate degree in biological/chemical sciences or related field strongly preferred
- Ability to effectively supervise regulatory technical staff.
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