Director, Regulatory Affairs CMC

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Boston, United States STEMSourcing Full time
  • Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for small molecule pipeline.
  • Represent regulatory-CMC on cross-functional project and technical teams.
  • Develop regulatory-CMC strategies based on regulatory and technical experience, provide guidance to teams on current phase-appropriate regulatory expectations, pro‑actively identify opportunities and risks, and work with teams to develop mitigations.
  • Lead regulatory-CMC discussions with regulatory authorities and preparatory activities (e.g., responses to information requests, requests for advice).
  • Prepare and manage regulatory-CMC submissions with phase-appropriate regulatory‑CMC strategies, ensuring on-time, high-quality, and accurate submissions aligned with company strategies and Health Authority requirements.
  • Review and provide regulatory assessments on change controls.
  • Ensure compliance with regulatory requirements and internal Standard Operating Procedures (SOPs).
  • Ensure regulatory-CMC conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es).
  • Interpret and assess impact of new regulations; identify potential opportunities/risks and coordinate with internal stakeholders to develop strategies to address any potential changes.
  • Support departmental objectives including the development of business processes, procedures, and/or templates to guide regulatory-CMC development.

REQUIREMENTS:

  • BA/BS required, Ph.D. or other graduate degree preferred. A minimum of 10 years of total pharmaceutical/related industry experience. A minimum of 8 years regulatory CMC experience.
  • The ideal candidate would have a strong background in regulatory affairs-CMC with expertise in small molecules/solid oral dosage forms, a deep familiarity with product development requirements particularly in late-stage development/NDA preparation and a strong understanding of global regulatory (FDA, EMA, PMDA, etc.) requirements and ICH guidelines.
  • Extensive experience in preparing quality sections of regulatory filings including Health Authority briefing packages, IND/IMPDs, and NDA/MAAs.
  • Strong technical background to allow understanding of technical aspects of manufacturing and analytical topics, and authoring of technical regulatory filings in collaboration with subject matter experts.
  • Experience working on project teams. Strong interpersonal skills and the ability to collaborate effectively with cross-functional representatives from manufacturing, analytical, quality assurance, program management, etc.
  • Proven ability to manage projects with cross-functional teams.
  • Excellent written and communication skills with attention to detail. Highly computer literate (Microsoft Word, PowerPoint), including document formatting for submissions. Familiarity with document management systems/regulatory information management systems is a plus.
  • The candidate should be a self-driven individual with strong organizational and communication skills as well as an ability to build effective working relationships.
  • Have and maintain in-depth knowledge and understanding of applicable US/EU regulations on the CMC development for small molecules. Assess impact of new regulations, manage regulatory-CMC documents, etc.
  • Remote with availability during East coast working hours. Some travel expected (~10%)

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