Position:  Director/Associate Director Regulatory Affairs
Location:  Cambridge, MA
Job Id:  017
# of Openings:  1

Reporting to the Head of Regulatory Affairs, the Director/Associate Director of Regulatory Affairs will work in an exciting and stimulating environment, leveraging state-of-the art science in a highly dynamic organization.Contribute to the development and implementation of innovative regulatory strategies for assigned projects and programs.This position may require travel as necessary to meet these objectives.
Key Duties & Responsibilities:
  • Plan and execute global regulatory strategies for a diverse portfolio of investigational products, including gene therapy, small molecules, biologics and devices
  • Lead cross-functional teams in the authoring preparation, review and submission of high quality investigational and marketing dossiers
  • Analyze the evolving regulatory environment and generate strategies to accelerate development and mitigate regulatory risks throughout the product lifecycle
  • Act as the internal regulatory accountable individual for global regulatory submissions and Health Authority interactions
  • Create submission plans and manage timelines and document workflow from draft through finalization for regulatory filings
  • Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed• Author/provide strategic guidance related to designations for expedited programs (eg, Breakthrough Therapy, PRIME) or special status (eg, Orphan Drug)
  • Perform literature searches, prepare special reports and assemble documentation to support project teams
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Perform other related duties as required by position
Education, Experience & Skills:
  • 7+ years regulatory drug development experience in biotech/pharma
  • Independently motivated, detail-oriented with good problem-solving ability
  • Excellent written and verbal communication skills
  • Experience managing and facilitating structured rounds of review of key documents
  • Ability to develop collaborative working relationships
  • Good organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
  • Working knowledge of US, EU and ROW regulations
  • Bachelor’s degree; advanced scientific related degree a plus
  • Orphan drug and/or gene therapy experience a plus
  • 0-10%

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