Director Regulatory Affairs

Location
Tarrytown, NY, United States
Posted
Aug 29, 2020
Ref
19859BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary
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 on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron's clinical asset candidates.

The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on regulatory filings and on providing strategic as well as operational leadership for 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 assets.
Job duties:
  • This role requires the ability to integrate and 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 state of compliance is maintained to all regulatory commitments/requirements.
  • Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management.
  • Provide regulatory analysis, guidance and assessment of drug(s) developed for similar indication to obtain approval of activities in support of Regeneron's development and marketing objectives within targeted timelines.
  • In charge of communication with FDA and health authorities for assigned programs.
  • Manage and lead regulatory activities associated with Regeneron assigned drug development programs.
  • Oversee 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 the need arises.
  • Manage and mentor direct team members and/or junior staff.
Job requirements:
MD, Ph.D. or Pharm D. required
A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory affairs
Must possess excellent written, verbal communication and presentation skills

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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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