What are the responsibilities and job description for the Director, Regulatory Affairs Strategy - Genetic Medicine position at Regeneron Pharmaceuticals, Inc?
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and / or supervise IND / CTA and BLA submissions activities.
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.
In this role, a typical day might include the following :
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
- Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval.
- Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
- Responsible for quality and timeliness of IND / CTA and BLA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
- Successfully plan, prioritize, supervise and / or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines.
- Provide interpersonal support and lead personnel.
- Excellent verbal and written communication skills.
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
- Ability to thrive in a fast-paced, entrepreneurial environment with successful colleagues.
- Ability to function at a high level in a team setting whether leading the group or acting individually.
This role might be for you if :
To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
This role requires you to work onsite 3 days per week in either Basking Ridge, NJ, Armonk, NY or Tarrytown, NY.
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