Sr. Director, Regulatory Affairs

  • Location: New York, New York
  • Type: Direct Hire
  • Job #17502

Senior Director, Regulatory Affairs

Location: New York, NY (Hybrid 3 days per week in office)

Salary Range: $220 – 255K

Summary: Oncology-experienced regulatory affairs specialist who will provide, develop and lead regulatory strategies to maximize global regulatory success towards achievement of clinical development programs involving investigational or marketed products and provide strategic and tactical advice to teams to achieve timely and efficient development of programs, while ensuring compliance with applicable regulatory requirements.

Reports to: CEO

Some Responsibilities:

  • Provide regulatory strategies, tactical guidance, information, training, support and overall corporate/strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
  • Ensure project team and key stakeholders are apprised of developments that may impact regulatory success.
  • Proactively anticipate risks and be responsible for developing solutions to identified risks and discussing with key stakeholders; understand probability of technical success for the solutions.
  • Lead submission types such as INDs, NDAs, BLAs, meeting requests with underlying information to FDA and other health authorities
  • Direct point of contact with FDA (and other health authorities as warranted), lead and manage FDA meetings and work with all relevant parties to successful outcomes. Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
  • Lead regulatory agency interactions, communications, and submissions, including assembly and submission of applications to competent authorities.

EDUCATION AND/OR EXPERIENCE:

  • BA/BS; advanced degree preferred.
  • Must have strong experience in hematology/oncology regulatory affairs.
  • Minimum 8 years of experience in clinical R&D and/or clinical research organizations focused on regulatory affairs with expertise from IND-submission to post-approval Phase 4 studies.
  • Extensive knowledge of clinical and product development life cycles for investigational and marketed health care products.
  • Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international.
  • Experience in authoring, reviewing and submitting all key components of regulatory submissions (orphan, fast track, breakthrough, NDA, BLA, etc).
  • Comprehensive knowledge of ICH-Good Clinical Practice (GCP), GMP, Quality Systems Management (ISO 13485).

OTHER SKILLS & ABILITIES:

  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Demonstrated ability to form strong working relationships across functional boundaries.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Ability and willingness to travel internationally.

For immediate consideration, email tomt@scientificsearch.com and mention Job# 17502. Check out www.scientificsearch.com for all of our openings.

 

#LI-TT1

#LI-HYBRID