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Regulatory Affairs (VP)

312

For a small clinical-stage biopharmaceutical company that uses technology for discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need.

The Director Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to develop submission content and strategy. This position reports into the Senior Director of Regulatory CMC.

Responsibilities:

 

  • Ensures high-quality and on-time submissions, including for early and late-stage INDs, IMPDs, CTAs and BLAs for complex biologics, that align with company strategies and Health Authority requirements. This includes strategic planning and assisting with writing the CMC dossier towards specific submission milestones (early to late phase). This includes interacting with cross-functional departments to ensure deliverables are met according to the corporate goals.
  • Strategically plan and assist with writing responses to CMC-related inquiries from regulatory authorities.
  • Preparation for Health Authority CMC meetings and development of meeting information packages along with cross-functional leads.
  • Provide regulatory and scientific expertise to review CMC source documentation in support of dossiers.
  • Provide oversight of detailed regulatory assessments for global CMC changes.
  • Represents Regulatory Affairs CMC on working groups and teams.
  • Develops relationships with and proactively communicates issues with key internal colleagues.
  • Develops and implements best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations.
  • Assists with creating, communicating, and implementing global submission strategies.
  • Oversight of change control regulatory assessments

Requirements:

  • Advanced degree in a scientific discipline with a strong understanding of protein chemistry.
  • 10+ years biopharmaceutical experience with a CMC focus
  • At least 8 years Regulatory CMC experience, biologics experience required.
  • Proven ability to manage projects. Capable of performing independently and thinking analytically and creatively to solve problems.
  • Excellent oral and written communication
  • Willingness to work through change and work toward continuous improvement
  • Experience in writing and developing late-stage documents with scientific content for IND and BLA submissions in eCTD format
  • Knowledge of early and late-stage CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries
  • Understanding of scientific principles and capable of interpreting regulatory requirements.
  • Understanding of global regulations and guidance (examples: GMP, CFR, FDA guidance, EU, ICH, Health Canada, ISO)
  • Direct experience participating in regulatory interactions with health authorities
  • Ability to influence decisions with effective communication skills

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