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 plan, prepare and manage complex submissions for US and global filings.  Reporting into the Head of Regulatory Affairs, you will work closely with cross-functional teams and interact with health authorities.  This company offers a strong development pipeline, competitive compensation, and a supportive company culture. This position can be remote with some regular visits to the Cambridge office.  Now is an exciting time to join this innovative organization and improve the lives of patients in need!

Responsibilities:

  • Develop and implement regulatory filing strategies for a portfolio of synthetic biologic programs in development.
  • Plan, prepare, and manage complex regulatory documents for US and ex-US submissions.
  • Work with publisher to manage all operational aspects of preparing compliant submissions to Regulatory Agencies.
  • Provide regulatory strategy and guidance to global product owner and project team.
  • Make recommendations to shape the global strategy in line with regional and commercial objectives.
  • Ensure that planned development activities are compliant with US and global regulatory guidelines.
  • Provide critical analyses of the any regulatory risks and issues.
  • Interface with FDA and various other authorities.
  • Help prepare for health authority meetings including preparation of meeting documents, meeting requests, meeting packages, etc.
  • Ensure that filing teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist in planning and issue resolution during product development.
  • Interact as appropriate with outside vendors, suppliers, contract research organizations, and others.
  • Critically review complex reports, protocols, etc. for scientific merit and regulatory appropriateness.
  • Serve as a resourceful and collaborative team member to help inform strategic decisions.

 

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.
  • 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.
  • Prior experience with regulatory operations and eCTD publishing.
  • Rare disease experience a plus but not required.
  • Extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
  • Experience interfacing with FDA including meeting preparation. 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.

 

Note: Although this is a remote role, our client prefers candidates who are on the East Coast.

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