Regulatory Affairs Director

This clinical stage company is developing innovative biologic therapeutics for the treatment of serious and rare diseases. They filed their first BLA this year and are anticipating commercial approval in the next six months. They are seeking a Regulatory Affairs Director (or Sr. Director) to lead regulatory strategies and execution for their Phase 2 Pulmonary program along with other early stage programs.  You will lead INDs and CTAs and work directly with US and global health authorities. This company offers competitive compensation and outstanding employee benefits, including flexibility to work from home regularly.  Now is an exciting time to join this growing company and help to get life-changing products approved!

Responsibilities

  • Lead regulatory strategy and execution for clinical stage biologic programs in the pulmonary therapeutic area.
  • Act as the primary regulatory representative for assigned programs and provide strategic regulatory guidance to project teams and sub-teams.
  • Lead the planning and preparation of global regulatory global submissions (INDs, CTAs, and an eventual BLA).
  • Serve as the liaison between the company and regulatory agencies (FDA, EMA, etc.) for assigned projects.
  • Coordinate and prepare responses in response to Regulatory Agency requests.
  • Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies
  • Prepare regulatory development plans and manage regulatory timelines for assigned projects.
  • Develop and maintain regulatory knowledge of US, EU and ROW regulations
  • Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company.
  • Maintain active INDs/CTAs (amendments and annual reports).
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents. Participate in initiatives aimed at improving internal departmental standards and systems

Qualifications

  • Bachelor’s degree in a scientific discipline. Advanced degree (MS, PhD, MD, Pharm D) a plus.
  • 8+ years direct regulatory affairs strategy experience with novel development programs in the Biotech/BioPharma industry.
  • Direct experience with the preparation and review of INDs and/or CTAs. NDA or BLA experience a plus.
  • Experience working with biologics highly desired. Orphan Drug experience preferred but not required.
  • Ability and experience in using eCTD format and templates for eCTD publishing.
  • Experience working with US or global health authorities, preparing meeting requests and briefing books.
  • Excellent communication skills and ability to effectively work in a team environment while developing peer relationships.
  • Must be highly organized and have the ability to meet critical deadlines.
  • Ability to work independently and proactively in a fast-paced environment.

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