Regulatory Affairs Director or Sr. Director

This clinical-stage pharmaceutical company is developing and commercializing innovative therapies for women’s health and prostate cancer.  With multiple programs in Phase 3, they are seeking a Regulatory Affairs Director or Sr. Director who can develop regulatory strategies and manage upcoming NDA submissions for their women’s health programs.  You interact directly with the FDA and cross functional teams, while also managing a small team of regulatory associates.  This company offers an incredible company culture, competitive compensation, equity, and great employee benefits.  Now is an exciting time to join this growing organization and to help get new women’s health products approved!

Responsibilities: 

  • Develop regulatory strategies and assist in the design of nonclinical and clinical study programs for designated women’s health programs.
  • Lead the filing of upcoming NDAs along with INDs, CTAs and other submissions in the US and globally.
  • Serve as liaison with FDA and other health authorities. Prepare for, plan and conduct FDA meetings.
  • Provide interpretation of regulatory authorities’ feedback, policies and guidelines to senior executives.
  • Work with project teams to resolve complex project issues.
  • Strategically interpret, plan, and communicate regulatory requirements to cross-functional teams to ensure that governmental approvals are obtained.
  • Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Assure compliance with project team timelines and milestones.
  • Manage a small team of regulatory associates and provide organizational support.

Knowledge and Skills:

  • BS degree in life sciences or related scientific discipline. Advanced degree (MS, PhD, PharmD) preferred.
  • At least ten years of industry experience with eight or more years in Clinical Regulatory Strategy for pharmaceutical drugs or biologics.
  • Must have experience with successful NDA/BLA and/or MAA filings.
  • Broad experience across all aspects of Regulatory Affairs including clinical regulatory strategy, regulatory CMC, and nonclinical regulatory affairs.
  • Solid knowledge of FDA and ICH guidelines and regulations for pharmaceuticals.
  • Experience working directly with FDA and other health authorities, including meeting preparation and presentation.
  • Prior experience managing direct reports desired. Must be able to lead and influence across the organization.
  • Excellent organizational and project management skills.
  • Outstanding written, verbal and interpersonal communications skills.
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
  • Must be collaborative, flexible, and unafraid to express opinions.

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