Associate Director, Gene Therapy Regulatory CMC
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
For an assigned product, The CMC Product lead develops and communicates CMC regulatory strategies that are in alignment with project goals and timelines. This includes formulating the global CMC strategy for the Global Regulatory Plan, with input from regional regulatory representatives and CMC SMEs; preparing CMC documentation to support global regulatory filings, including liaising with GRT regional representatives and relevant SMEs to draft technical content for CMC submissions.
You’ll be responsible for:
- Proactively managing CMC aspects of one or more development programs including overseeing preparation and submission of global CMC submissions, including clinical trial applications.
- Ensuring that CMC content is complete, well-written, and meets all relevant requirements.
- Evaluating proposed manufacturing changes for global impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.
- Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
- Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
- Managing interactions with FDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of clinical trial applications and other submissions which present CMC information.
- Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree preferred.
- 6-8 years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise clinical phase submissions and health authority interactions.
- Experience with Gene Therapy products.
- Thorough understanding of relevant drug development regulations and guidelines is essential.
- Outstanding interpersonal and communication (written and verbal) skills is required
- Strong writing and editing skills for technical documentation.
- Proficient with computer and standard software programs.
- Able to travel 10%.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.