Sr. Manager, Regulatory CMC

San Rafael, CA

Employer:

Description

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.

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 for Marketing Application (new and renewals), Post-approval Variations, and periodic reports for North America and Intl markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.

Collaborating and alignment with Reg CMC Product Lead regarding change record assessments of proposed manufacturing changes and regulatory strategy, provide strategic regulatory guidance for optimal implementation to cross-functional stakeholders.
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 to global Reg CMC Product Lead and Portfolio Lead.
Develop relationships with Regulatory Affairs, Technical Development (Process Technologies/Analytical Sciences), Sites (internal and external), 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

Assist with regulatory authority (FDA, Health Canada) interactions for assigned projects such as pre-Agency meeting requests, briefing packages.
Leading and/or assisting in responding to country health authority queries.
Knowledge management of global marketing authorization and post approval change requirements
Work in Regulatory and Quality databases via Veeva platform

EDUCATION

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

EXPERIENCE

At least 7 years of experience in Regulatory Affairs CMC or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle). Marketed Products experience required.
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
Thorough understanding marketing authorization registrations and post-approval change variation guideline.
GMP environment (clinical and commercial), with understanding of multi-product facilities.

Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs.

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.

In the U.S., the salary range for this position is $ 122,600 to $ 183,900 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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