Sr. Manager, Regulatory CMC (APAC Region)

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 commercial product submissions in the specific countries in APAC regions to enable commercial product approvals and post approval submissions by:

RESPONSIBILITIES

Working closely with Regulatory Int'l (Regional Regulatory Teams) and Regulatory CMC (Global REG CMC Product Lead) to prepare, review, and approve international regulatory submission documents and Medical Device related content for Marketing Applications (new and renewals) and Post-approval Variations/Submissions. Ensure that the sections are complete, well-written, and meet all relevant country specific CMC and Medical Device requirements.
Proactively identify issues and escalate to global Reg CMC Product Lead.

Creating, identifying, collecting, and entry of regulatory affairs information of medical devices.

Collaborate with Regulatory Int'l (Regional Regulatory Teams) and Regulatory CMC (Global REG CMC Product Lead), using internal systems as applicable, to obtain strategic alignment for change record assessments of proposed manufacturing changes which may impact already approved APAC regions

Manage Information Requests from Health Authorities and archive all relevant communications in the internal systems such as Veeva platform.
Develop relationships with cross-functional teams and ensure communications regarding requests from Regulatory Int'l (Regional Regulatory Teams) are responded to in a timely manner
Provide regulatory advice to technical subject matter experts based on knowledge of current CMC requirements from ASEAN, WHO, and APAC regions.
Collaborate with regional RA teams, using internal systems as applicable, to obtain strategic alignment for submission and schedules for each country

Assist with regulatory authority interactions for assigned APAC projects such as pre-Agency meeting requests, briefing packages, correspondence as required.

EDUCATION

Life Science Degree 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.
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.

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