Regulatory Affairs Director or Sr. Director

This client is a privately-held, pre-clinical stage biopharma company in South San Francisco which is developing cell and gene therapies for heart failure.  They are seeking a Regulatory Affairs Director or Sr. Director to establish the regulatory function and recommend strategies to bring their innovative programs into the clinic and advance them towards approval. This is a unique opportunity to manage all regulatory activities and contribute to major company decisions. This company offers a dynamic start-up environment, competitive salary, stock options, excellent benefits, and the potential to work from home 1-2 days a week.

Responsibilities:

  • Identify and recommend strategies for successfully and efficiently achieving product approvals in G7 geographies, including exploration of expedited paths.
  • Serve as the primary liaison with regulatory authorities for the specific programs.
  • Plan, prepare, and review submissions to regulatory authorities including FDA (CBER), EMA (ATMP/CAT), PMDA and other major national regulatory authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA).
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities.
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities.
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
  • Bring the Regulatory Affairs functional perspective to the table as the company makes important early decisions about nominating development candidates and building a diverse pipeline of programs and indications.
  • Making the case for strategic decisions to the Management Team, Board, and other advisory groups, including related to product development, study design, acceleration opportunities, etc.
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
  • Recruit a broader team of regulatory professionals as needed over time, and identify and retain consultants where needed.
  • Act as the global regulatory lead with early, pre-clinical experience to the end of Phase II and represent the regulatory function on related cross-functional program teams.
  • Work with project teams to resolve complex project issues.
  • Monitor, analyze, disseminate, and recommend actions based on intelligence on regulatory matters that may affect the company and ongoing development programs.

Qualifications:

  • BS in scientific field required.  MS, PhD or PharmD preferred.
  • 8 to 15 years of regulatory affairs experience in the biopharma industry.
  • Regulatory experience with innovative therapies (biologics, cell therapy, gene therapy or another novel modality) is highly desirable.
  • Demonstrated track record of engaging thoughtfully, creatively, and collaboratively with regulatory agencies to create a path for a new modality to advance into and through the clinic.
  • Experience engaging with regulatory agencies at different stages and filing relevant submissions.
  • Early preclinical development consultations through IND/CTA and eventually end of Phase II is a must.
  • Recent experience with BLA/NDA/MAA submissions and product lifecycle management is a plus.
  • Thorough knowledge of relevant FDA and EMA regulations that are relevant to cGMP manufacturing environments.
  • Global experience is highly preferred, including interactions with EMA and EU national authorities (e.g. UK, France, Germany) and/or Japanese PMDA is a plus.
  • Knowledge of and experience working in the cardiovascular field in general – and the heart failure field in particular – is a plus but not required.
  • Demonstrated ability to plan and execute; excellent analytical skills and an ability to communicate complex issues to a broad audience (oral and written).
  • High bandwidth for implementing technical, strategic, and operational plans with a proven track record in identifying and resolving critical issues.
  • Outstanding communication skills, with the ability to articulate a strategy and build support internally and externally.
  • Must thrive working in a fast-paced, innovative environment requiring flexibility, strategic agility, and creativity.

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