The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to ongoing clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron’s clinical oncology candidates.
- This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron’s quality, preclinical and clinical drug development programs, policies and procedures, so that development teams can meet all objectives within specified timelines and so that the necessary
state of compliance is maintained relative to all regulatory commitments/requirements.
- Develop regulatory strategies for assigned programs in collaboration with Regeneron’s Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines.
- Liaison responsible for communication with FDA and other health authorities for assigned programs.
- Manage/lead regulatory activities associated with Regeneron assigned oncology drug development programs.
- Management of the planning, preparation and submission of licensing applications (BLA/MAA).
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
- Manage and mentor direct reports and/or junior staff members.
- JOB REQUIREMENTS:
- Ph.D., PharmD, or MD required
- A minimum of 10 years of pharmaceutical industry experience
- 4-5 years experience in oncology regulatory affairs required
- Must possess excellent written and verbal communication skills
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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