6 months ago
The Sr. Director, Regulatory Affairs will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This individual will direct and coordinate activities in regulatory and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around this critical functional area. S/he will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively, interacting closely with internal peers and externally with FDA, EMA, and other key stakeholders.
S/he must not only be adept at formulating and driving strategy, but also be tactically oriented, preparing and writing submissions and playing a hands-on role in regulatory submissions. Furthermore, this individual will have demonstrated an ability to partner effectively with multiple functions, including Clinical, Research, Development, Medical Affairs and Quality. At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science. Strong interpersonal skills are necessary, as this individual will serve as a voice for the company internally as a trusted member of the team. A proven ability to communicate with other members of the executive management team, board members, external thought leaders, and research and development staff in a fast-paced environment is crucial. Furthermore, the capacity for strategic thinking is highly important. In short, outstanding leadership and management skills with rigorous scientific intellect and standards and understanding of the business aspects of drug development are required. Finally, an ability to think and manage strategically, with an attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.
This position will report to the VP, Regulatory Affairs and ideally be based in the company corporate offices in norther California.
- Provide high level strategic and operational regulatory direction and mentorship on clinical development programs in endocrinology
- Work closely with commercial, clinical development and Medical Affairs in designing and implementing development and launch strategies and life cycle planning
- Contribute to labeling, advertising and promotional materials
- Lead BLA activities (e.g., Preclinical, Clinical) with functional expert
- Lead, develop, and manage the Regulatory Affairs team
- Contribute to development of best practices and standardized process for filing of regulatory submissions
- Contribute to internal regulatory policies and procedures to achieve best practices and work processes
- Master’s degree within Life Science and experience working as a RA project lead of BLA and/or NDA filings
- Minimum 15 years of documented professional experience at a Regulatory Affairs position from a pharmaceutical/biotechnology company developing biologics, small molecules, or synthetic peptides
- Have a strong understanding of clinical development and how to present clinical data to FDA
- Experience with labeling development and in close collaboration with marketing and market access departments
- Experience working with a drug device combination product preferred
- Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labeling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market
- Demonstrated an ability to collaborate effectively with multiple functions, including Research, Development, Clinical, Commercial, and Quality
- Ability to travel up to 30-40 days per year domestically and internationally
- Preferred candidates will have a broad blend of experience in Regulatory Affairs and have worked directly with FDA and other international agencies on clinical and regulatory matters
- Must have a proven success track record of developing short- and long-term regulatory affairs and clinical strategies to deliver innovative medicines to the market
- Recent filing experience globally, U.S. and European regulatory authorities required, experience with Asia / Pacific region a plus
- Deep familiarity with the overall drug development process especially related to clinical trial requirements for submissions required
- Experience with Orphan Drugs development and fast track regulatory processes
- Experience with BLA/NDA filing a must; experience with other filings highly desirable- IND filings, PSPs, PIPs, orphan, and breakthrough product applications.
- Familiarity with combination products of drug-device is a plus
- Strong leadership experience and capabilities are essential
- Previous mentorship experience of junior regulatory staff
- Proven ability to lead and manage regulatory team from a distance (joint locations)
- Leadership polish and gravitas
- Previous successful experience leading / participating in FDA / EMEA or other regulatory meetings
- Excellent writing, communication, and presentation skills #LI-AM2