Senior Manager - CMC Regulatory

BioMarin Senior Manager Regulatory CMC

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best people with the right technical expertise and a relentless drive to solve real problems and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical, and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

Duties

This role is Hybrid (2 days on site) but candidates must be PST - West Coast California.

As a Senior Manager in the Regulatory CMC department, this individual will be responsible for :

• Planning, preparation, and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing applications, 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 and staying aligned 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 reviewing regulatory documents to ensure that all submissions are complete, accurate, and meet relevant requirements.
• Managing the timelines and deliverables to ensure submissions are aligned with program milestones.
• Proactively identifying issues and escalating.
• Developing relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality to support submission preparation.
• Providing regulatory advice to technical subject matter experts based on knowledge of current Quality (CMC) requirements.
• Processing documentation requests to support key application activities.
• Managing interactions with country regulatory authorities (FDA, EMA, HC, etc.) for assigned projects relating to health authority queries.

Skills

Education

Note : This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer / Veterans / Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.