Manager, Regulatory Affairs-hybrid

3 weeks ago

Philadelphia, United States Adaptimmune Full time
Job DescriptionJob Description

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

PRIMARY RESPONSIBILITY 

Under the supervision of Senior Regulatory Affairs staff, the Manager, Regulatory Affairs is responsible for developing, implementing, and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle.  Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies.  Identifies and assesses regulations and guidance documents provides interpretive guidance applicable implementation.  This position will work within cross-company development project teams and will provide regulatory expertise into strategic regulatory plans.

Key Responsibilities

  • Contributes to the development of the global regulatory strategy and executes regulatory strategies for assigned projects
  • Preparation of regulatory submissions including: INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
  • Serves as the primary liaison with FDA and other regulatory agencies throughout development of projects, including support for regulatory agency meetings and teleconferences
  • Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; and provide interpretive guidance and ensure applicable implementation into development planning and execution
  • Ensures that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance
  • Represents Global Regulatory Affairs as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings
  • Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes
  • Ensure regulatory documentation is maintained appropriately
  • Other duties as assigned
     
Qualifications & Experience

Required
  • Bachelor’s Degree required; advanced degree preferred
  •  Experience in drug development process
  •  Minimum 3 years of Regulatory Affairs experience
  • Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)
  • Solid working knowledge of relevant domestic and global regulations and guidance
Desirable
  • Experience in cell and gene therapy and/or oncology is strongly preferred
  • ​​​​​ Experience with BLAs/NDAs/MAAs preferred

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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