Biopharmaceutical ONCOLOGY company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells.

The company has built up robust operational and supply chain capabilities to successfully deliver cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

 

 

 

 

Project Management: Act as a Regulatory Project Manager in planning, coordination and tracking CMC dossier towards marketing registration biological licensing application. Interact with cross-functional departments for deliverables are met according to the company’s timelines.

Regulatory CMC Lead: Represent Regulatory Affairs CMC perspective to teams. Provide regulatory CMC guidance on FDA and global requirements to the team. Prepares and submit high quality regulatory submissions to the FDA and other health authorities in accordance with regulatory guidelines and applicable federal laws.

  • Prepares CMC sections of regulatory submissions for cell and gene therapy products in various phases of product development life-cycle. Define CMC content (data and documentation) resulting in high quality submissions.
  • Responsible for regulatory CMC review of regulatory document, reports and data for conformance with the requirements and expectations of health authorities.
  • Serve as Regulatory Affairs CMC Project Manager, liaise with cross functional departments; strategize and plan for timely registration submissions in the Unites States and other countries assigned.
  • Work closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.
  • Serve as Regulatory Affairs CMC lead for assigned project in deliver high quality CMC dossier suitable for registration and subsequent post-approval CMC activities.
  • Compile, review and approve CMC documents/modules for assigned marketing registration applications accordingly to regulatory requirements. Coordinate response to information request as well.
  • Work with Tech Ops team in providing regulatory CMC requirements and resolve technical issues.
  • Prepare CMC briefing package for various agency meetings.
  • Interact with FDA under the guidance of department head.
  • Maintain relevant cell gene CMC knowledge base of existing and emerging regulations, standards, or guidance and provide interpretive assistance to cross-functional teams.
  • Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Advanced Degree in Science desired.
  • 4+ years of related biologics (cell/gene therapy highly preferred) industry experience with a minimum of 3 years in Regulatory Affairs.
  • Demonstrated project management experience can work in a cross-functional team environment to develop, implement and deliver on project goals.
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.
  • Proven ability to manage projects. Capable of performing independently and thinking analytically and creatively to solve problems.
  • Recent experience in preparing CMC sections of INDs/BLAs for cell and gene therapy products is required. International regulatory experience is a plus.
  • Successful track record in delivering regulatory projects.
  • Solid wording knowledge of CMC requirements for biologics in development towards marketing registration in the United States.
  • Understand drug product development progress.
  • Understanding of scientific principles and capable of interpreting regulatory requirements.

Salary:

$135K - $160K + 15- 20% Annual Bonus plus LTI

Location:

Remotely based at current home location

Relocation:

No, not at this time.

Code:

HY- 1832