Director, Regulatory Affairs - Oncology

Location
Tarrytown, NY, United States
Posted
Jan 09, 2021
Ref
20522BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
SUMMARY:
The Director Regulatory Affairs - Oncology 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 oncology. 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.
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 oncology 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 oncology programs.
  • Manage and lead regulatory activities associated with Regeneron assigned oncology 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, PhD or Pharm D required
Minimum 4-5 years experience in oncology regulatory affairs required
Must possess excellent written, verbal communication and presentation skills

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