Sr. Manager, Regulatory CMC

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 for:

RESPONSIBILITIES
Planning, preparing, and submitting global regulatory CMC-related content for Marketing Applications (new and renewals), Post-approval Variations, and periodic reports for North America and international markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.

Collaborating and aligning with the Reg CMC Product Lead regarding change record assessments of proposed manufacturing changes and regulatory strategy, and providing 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.

Managing the timelines and deliverables to ensure submissions are aligned with program milestones.

Proactively identifying issues and escalating them to the global Reg CMC Product Lead and Portfolio Lead.

Developing relationships with Regulatory Affairs, Technical Development (Process Technologies/Analytical Sciences), Sites (internal and external), 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.

Assisting with regulatory authority (FDA, Health Canada) interactions for assigned projects, such as pre-Agency meeting requests and briefing packages.

Leading and/or assisting in responding to country health authority queries.

Knowledge management of global marketing authorization and post-approval change requirements.

Working in Regulatory and Quality databases via the Veeva platform.

EDUCATION
A BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. An 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).

Experience with Marketed Products is required.

Experience in filing post-marketing supplements, INDs, and CTAs for pharmaceutical or biologic products in the U.S. and/or Europe is required.

Thorough understanding of relevant drug development regulations and guidelines.

Thorough understanding of marketing authorization registrations and post-approval change variation guidelines.

Experience in a GMP environment (clinical and commercial), with an 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.

The salary range for this position is: $122,600 to $183,900. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Apply here