Senior Manager - CMC Regulatory

Job Details
Who We Are
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.
DutiesThis 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/accountable for:
RESPONSIBILITIES

• 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 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.

• Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
• Proactively identify issues and escalate.
• Develop relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality to support submission preparation.
• Provide regulatory advice to technical subject matter experts based on knowledge of current Quality (CMC) requirements.

• Process documentation requests to support key application activities

• Manage interactions with country regulatory authorities (FDA, EMA, HC, etc) for assigned projects relating to health authority queries.

Skills Education

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.

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.
Company
At BioMarin, we translate the promise of genetic discovery into medicines that make a profound impact on the life of each patient.
Since our founding in 1997, we've developed a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, we seek to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world.
As we have looked to expand our impact, our approach to cutting-edge science has remained the same. 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.
Company info
Website Location San Rafael and Novato
California
United States
Share this job

• Facebook
• Twitter
• LinkedIn