Associate Director/Director, Regulatory CMCLocation San Rafael, California
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
This position is responsible for providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products, including the oversight and generation of quality dossiers to support clinical trial applications and market applications in the U.S. and multiple international territories. This role involves working closely with CMC teams, regulatory CMC individuals, and interactions with global health authorities to achieve alignment on the regulatory strategies to achieve product registration. Expertise and knowledge of global regulations and guidance for the development of gene therapy products is desired.
- Oversee the development, planning, and execution of global regulatory submission strategies in line with corporate/department goals and timelines
- Ensure that the CMC content is complete, well-written, and meets all relevant requirements
- Assess proposed manufacturing changes and provide strategic regulatory guidance as to how to best implement changes globally.
- Represent Regulatory Affairs CMC on assigned cross-functional project teams
- Provide regulatory advice to Technical Operations departments based on knowledge of current regulatory requirements and evolving/ current expectations
- Develop excellent relationships with internal functional groups, including Research, Technical Operations, Quality, and other regulatory functions
- Manage interactions with FDA or other regulatory health authorities for assigned projects
- Support departmental initiatives, including special projects, budgeting, and training
- Experience managing regulatory professionals
Ph.D. in biological or physical science is preferred. MS/BS is acceptable with appropriate relevant experience.
- The ideal candidate should have a strong background in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in product development.
- At least 6-10 years in Regulatory Affairs, CMC and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products
- Experience with the compilation and management of global clinical trial applications and corresponding environmental risk assessments and other environmental assessments, such as the Cartagena in Japan, for gene therapy products.
- Experience assessing manufacturing process changes and managing clinical trial applications over the life of the product
- Proven ability to successfully interact with regulatory authorities in meetings and general correspondence
- Thorough understanding of domestic and international drug development regulations and guidelines and experience with submission and approval of market applications, and managing the regulatory review process leading to product registration
- Outstanding interpersonal and communication skills (written and verbal) is required
- Proficient with computer and standard software programs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.