Regulatory Affairs Associate Director or Director

This growing biopharmaceutical company uses a proprietary synthetic biology platform to develop treatments for a variety of rare metabolic and autoimmune diseases.  They are seeking a Regulatory Affairs Associate Director or Director who can contribute to regulatory strategies for multiple programs in development.  Reporting into the Head of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with health authorities.  This company offers a strong development pipeline, competitive compensation, and a supportive company culture.  Now is an exciting time to join this innovative organization and improve the lives of patients in need!

Responsibilities:

  • Serve as the Regulatory Lead on product teams, providing regulatory strategy and guidance to the global product owner and project team.
  • Work collaboratively with cross-functional teams to resolve complex project issues.
  • Make recommendations to shape the global strategy in line with regional/commercial objectives.
  • Author and prepare regulatory documents (e.g., briefing books, responses to Health Authorities, etc.) with input from the relevant stakeholders and subject matter experts
  • In alignment with the Head of Regulatory Affairs, develop and advise project team on regulatory strategy and implementation processes for various program activities.
  • Review documents for regulatory submissions with attention to detail for quality, regulatory compliance, technical merit, and strategic alignment.
  • Contribute to Regulatory Strategy Documents and corporate presentations.
  • In collaboration with Head of Regulatory Affairs, serve as Regulatory liaison/interface to Health Authorities, with the expectation to develop, foster, and maintain professional relationships.
  • Lead/participate in Health Authority meetings in collaboration with the Head of Regulatory Affairs.
  • Ensure planned development activities compliant with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
  • Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development.
  • Maintain clear communication and professional relationship with functional areas inside and outside regulatory.
  • Interact with outside vendors, suppliers, contract research organizations, and others, as appropriate, to manage regulatory activities.
  • Critically review complex reports, validations, etc. for scientific merit and regulatory suitability.
  • Interpret and advise project teams regarding compliance regulations.

Required Qualifications:

  • Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • Six or more years of experience in Regulatory Affairs for pharmaceutical drugs and biologics.
  • Strong regulatory experience with clinical development. Prior biologics experience a must.
  • Extensive experience interfacing with Health Authority personnel (prior experience leading a Health Authority meeting preferred)
  • Proven skill with implementing successful regulatory strategies with US FDA (global regulatory experience is a plus)
  • Must have direct experience with IND and CTA filings. Experience in preparing major drug applications (NDA, BLA, NDS, MAA, etc) highly desired.
  • Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment.
  • Rare disease experience a plus but not required.
  • Extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
  • Experience with ex-US health authorities highly desired.
  • Flexibility with ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and adjust to new information or changing priorities.
  • Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
  • Self‐motivated, self‐disciplined, and able to function independently as well as part of a team.
  • Must be comfortable working for a small organization, and able to handle ambiguity and change.

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