Manager-AD, 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.
- Oversee the planning, preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for US and Ex-US markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.
- Collaborating with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
- Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
- Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
- Proactively identify issues and suggest appropriate strategies to mitigate risks.
- Develop relationships with internal functional groups, contract manufacturing organizations, and partners.
- Provide regulatory advice to technical operations departments based on knowledge of current requirements.
- Process documentation requests to support key application activities
- Manage interactions with FDA or other regulatory authorities for assigned projects.
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
- At least 3 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle)
- Experience in filing post-marketing supplements, INDs, CTAs for pharmaceutical or biologic products in the US and/or Europe is required.
- Thorough understanding of relevant drug development regulations and guidelines
Outstanding interpersonal and communication (written and verbal) skills; 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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.