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 various treatment modalities.

Using our expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical needs. We recruit talented individuals with the right technical expertise and a drive to solve real problems, creating an environment that empowers our teams to pursue innovative science. Our approach has resulted in a diverse pipeline of candidates that are either first-to-market or offer significant benefits over existing therapies.

About Worldwide Research and Development

Our WWRD engine encompasses all bench and clinical research activities, supporting the development of first-in-class and best-in-class therapeutics for genetic diseases.

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

Responsibilities

1. Planning, preparing, and submitting global regulatory CMC content for marketing applications, post-approval variations, and periodic reports for North America and international markets, aligned with regulatory strategies. Ensuring completeness, clarity, and compliance of submissions.
2. Collaborating with the Reg CMC Product Lead on change assessments and regulatory strategies, providing guidance for manufacturing changes.
3. Developing and reviewing regulatory documents to ensure accuracy and compliance.
4. Managing timelines and deliverables to meet program milestones.
5. Proactively identifying issues and escalating as needed.
6. Building relationships with Regulatory Affairs, Technical Development, Sites, and Quality teams to support submissions.
7. Providing regulatory advice to technical experts based on current Quality (CMC) requirements.
8. Processing documentation requests for key application activities.
9. Assisting with interactions with regulatory authorities such as the FDA and Health Canada, including pre-Agency meetings and briefing packages.
10. Leading or supporting responses to health authority queries.
11. Managing knowledge of global marketing authorization and post-approval change requirements.
12. Using Veeva platforms for regulatory and quality database management.

Education

• Bachelor's degree in life sciences such as chemistry or molecular biology; advanced degrees are a plus.

Experience

• Minimum of 7 years in Regulatory Affairs CMC or related fields within the pharmaceutical or biotech industry, with experience in both development and commercial phases. Experience with marketed products is required.
• Experience filing post-marketing supplements, INDs, and CTAs in the US and/or Europe.
• Deep understanding of drug development regulations and guidelines, marketing authorization processes, and post-approval change regulations.
• GMP environment experience, with knowledge of multi-product facilities.

Excellent interpersonal and communication skills, proficiency in standard software applications.

Note: This description is not exhaustive and may include additional duties as assigned.

Equal Opportunity Employer/Veterans/Disabled

BioMarin is committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

The salary range for this position is $122,600 to $183,900, depending on experience, qualifications, and location. Benefits include medical, dental, vision, life insurance, bonuses, stock incentives, paid time off, and more. For details, visit