Regulatory Affairs Manager

This small, clinical stage pharmaceutical company is developing life-changing therapies for genetic diseases.  With their lead candidate for DMD in Phase 3, they are seeking a Regulatory Affairs Manager to join their growing team.  You will contribute to and execute upon global regulatory strategies for multiple programs in development, and support an upcoming NDA.  You will also represent Regulatory on cross-functional teams and interact with health authorities.  This company offers competitive compensation, excellent employee benefits and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need!

Responsibilities:

  • Prepare, review and approve regulatory submissions (INDs, CTAs amendments, annual reports, orphan designations, and pediatric investigation plans etc.) to the FDA and other regulatory authorities.
  • Support the Senior Vice President with an upcoming NDA filing including the preparation of regulatory documentation and submission activities.
  • Create submission plans and manage timelines and document workflow from draft through finalization for submissions.
  • Prepare both routine and complex submissions in compliance with department and regulatory requirements and guidelines.
  • Interact with the FDA and other regulatory authorities to facilitate approval of the regulatory submissions.
  • Work with team members to identify resource requirements and strategies to address overlapping resource demands and rate limiting factors.
  • Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.
  • Ensure regulatory plans are monitored, progress/variance communicated, and any risks are highlighted.
  • Collaborate within regulatory and cross-functional colleagues. Interact with various departments as needed on regulatory issues and/or strategy.
  • Effectively guide, communicate and implement determined strategy with the appropriate departments and/or employees.
  • Implement policies to assure on-going compliance of Regulatory Affairs activities.
  • Assess the impact of new regulations and suggest appropriate changes to business processes/policies as necessary.
  • Maintain awareness of all regulatory activities on assigned projects. Work to minimize regulatory issues and helps prevent unnecessary regulatory delays.

Required Qualifications:

  • BS. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • 5+ years of experience in Global Regulatory Affairs for pharmaceutical drugs and/or biologics.
  • Direct experience in preparing regulatory submissions (INDs, CTAs) required. Experience with Marketing Applications (NDA, BLA, and/or MAA) a plus.
  • Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule drug products.
  • Experience with rare disease indications a plus.
  • Strong project management and organizational skills with emphasis on attention to detail
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.
  • Self‐motivated, self‐disciplined, and able to function independently as well as part of a team.
  • Strategic agility, strong critical and logical thinking with the ability to analyze and propose solutions to problems.
  • Must be a team player who is comfortable wearing many hats in a small biotech environment.

NOTE: All applicants must be authorized to work in the United States.  Our client cannot support visa sponsorship or an H1B transfer.

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