Position Summary:

The primary role of this position is to provide regulatory CMC advice and direction, including the interpretation and application of global CMC regulations and guidance, to facilitate the development of products from early phase clinical trials through to worldwide submission and approval.

Specific responsibilities include:

  • Participation in or leadership of cross-functional subteams, development of regulatory strategies, and support for oncology development programs
  • Preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, meeting packages, etc.), to ensure timelines are met
  • Preparation of technical assessments of CMC source documentation and responses to technical questions on document content
  • Initiation and and/or contribution to local process improvements which have an impact on Regulatory Affairs or other departments
  • Involvement in preparation for and support of CMC interactions with regulatory health authorities

Requirements:

Minimum Education/Experience

  • Bachelor’s or Master’s degree (or equivalent) in life sciences
  • 5+ years of experience in regulatory affairs or related function within a biotechnology company
  • Direct experience managing regulatory CMC aspects of investigational biologic products essential, prefer experience with both mammalian and bacterial-derived products including vaccines, gene or cell therapy products


Qualifications

  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and contract manufacturing organizations
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Strong knowledge of cGMP for biologic products, understanding of biopharmaceutical development, and CMC regulatory affairs
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze and propose solutions to problems
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)