Associate Director, Gene Therapy Regulatory CMC
Location:London, United Kingdom
With accelerated review underway in the United States and Europe for our Hemophilia A drug, a second gene therapy program entering the clinic for PKU patients, and a third program in late research for Hereditary Angioedema, BioMarin continues to pioneer innovative approaches to treating rare diseases. Our commitment to gene therapy is further underscored by having developed the first and largest gene therapy manufacturing facility in the world. The scientific possibilities and the hope we offer to patients with rare diseases is enormous.
BioMarin is a midsize biotechnology company with a market cap of approximately 18 billion. Over the course of our 22 year history we have successfully launched 7 drugs for the treatment of rare diseases. Our success is due to our scientific rigor and our ability to leverage multiple therapeutic modalities. BioMarin is based in the San Francisco Bay Area and offers a comprehensive relocation program.
Check out the traits we’re looking for and see if you have the right mix.
- Decision Making
- Intellectual Curiosity
- Patient Focused
- Results Oriented
- Pioneering Science
- Cross Functional Collaboration
- Willing to try new ways to look at problems
Health & Wellness Programs
" BioMarin has this, in their own DNA, an approach: they only work on projects for which they know the underlying biology."Lon C., Chief Scientific Officer
"We’ve got to understand: What are the problems other people are trying to solve? And do we have a better way of fundamentally doing that?"Brinda B, GVP, Corporate and Business Development
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.
EU Regulatory Affairs team members works with US based project teams and subject matter experts to support the clinical development and life cycle management of gene therapy medicinal products. They are responsible for the timely generation of high quality submissions to support clinical trial initiation and market applications in the U.S., EU and multiple international. This role involves working closely with CMC teams, regulatory CMC individuals, and interactions with global health authorities to provide input and achieve alignment on the regulatory strategies for gene product development and commercialization. A level of expertise and knowledge of global regulations, guidance for the development of gene therapy products and strong technical expertise 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 scientifically robust, 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 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 or has strong analytical or manufacturing expertise in Advanced Therapy Medicinal Products or deep experience in product development.
- At least 6 years in Regulatory Affairs, CMC or relevant years in a technical or manufacturing environment with expertise in biologicals, 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
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.
About our location
Meet Our Team
From internationally renowned scientists to patient advocates, BioMarin Hemophilia has brought together the right people.Read More
In the News
BioMarin has entered into a preclinical collaboration and license agreement with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies.Learn More