Director, Regulatory CMC

BioMarin Pharmaceutical Inc.; San Rafael (CA); On-site; USD 184,000 - 276,000; Full time

Job summary

Join a pioneering biotechnology company focused on transforming genetic discoveries into groundbreaking medicines. As a Director in Regulatory Affairs, CMC, you will lead the development of global regulatory strategies, ensuring compliance and facilitating timely submissions. This role demands extensive experience in Regulatory Affairs CMC, particularly within the pharmaceutical and biotech sectors. You will collaborate with cross-functional teams, manage regulatory interactions, and mentor junior staff, all while contributing to innovative solutions for patients with genetic diseases. This is an exceptional opportunity to make a significant impact in a dynamic and supportive environment.

Qualifications

• 12-15 years in Regulatory Affairs CMC or related field.
• Proven leadership in managing CMC teams and submissions.

Responsibilities

• Develop global regulatory strategies for assigned products.
• Manage CMC aspects and ensure timely regulatory filings.
• Provide strategic guidance on manufacturing changes.

Skills

Regulatory Affairs CMC

Leadership in cross-functional teams

Interpersonal and communication skills

Knowledge of CMC drug development regulations

Experience with combination products

Education

BA/BS in life sciences

Advanced degree in relevant field

Tools

Global dossier management systems

Job description

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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 Director in Regulatory Affairs, CMC, you will be responsible for:

• Developing global regulatory strategies and preparing global CMC Regulatory strategy documents for assigned products.
• Managing Chemistry, Manufacturing & Controls (CMC) aspects of BioMarin’s programs, including timely preparation and submission of global regulatory filings.
• Evaluating manufacturing changes for regulatory impact and providing strategic guidance.
• Researching and interpreting global CMC regulations, providing guidance to various functional groups.
• Representing Regulatory Affairs CMC on cross-functional project teams.
• Managing interactions with global regulatory authorities to ensure acceptance and rapid review of submissions.
• Building relationships with colleagues and stakeholders in WWRD and Technical Operations.
• Providing strategic and tactical advice to junior team members on key projects.
• Traveling periodically for meetings and conferences.

Experience

Required Skills:

• 12-15 years of experience in Regulatory Affairs CMC or related discipline in pharma/biotech, with exposure to development and commercial phases. Experience with combination products is desirable.
• Experience managing and filing marketing applications, supplements, and variations across multiple regions.
• Experience assessing post-marketing changes.
• Proven leadership in cross-functional CMC teams.
• Thorough knowledge of CMC drug development regulations and guidelines.
• Excellent interpersonal and communication skills.
• Ability to work in a matrix environment with cross-functional teams.

Desired Skills:

• Regulatory CMC experience in US, CA, EU markets.
• Experience leading authoring teams for initial submissions and approvals.
• Experience with biologics and small molecules.
• Coaching, training, and mentoring skills.
• Ability to interact successfully with Regulatory Authorities.
• Background in chemistry, molecular biology, or similar fields is desirable.

Plus Skills:

• Project management skills.
• Device/Combination products experience.
• Experience with global dossier and document management systems.

Education

BA/BS in life sciences such as chemistry or molecular biology is required; an advanced degree is preferred.

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

Additional Information

Equal Opportunity Employer/Veterans/Disabled. Salary range: $184,000 to $276,000, with potential bonuses and benefits. For more details, visit: https://careers.biomarin.com/benefits.