Director, Regulatory CMC

BioSpace; San Rafael (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player seeks a Director in Regulatory Affairs, CMC. This pivotal role involves developing global regulatory strategies and managing CMC aspects for innovative therapeutics. You will lead cross-functional teams, ensuring compliance with CMC regulations while mentoring junior staff. If you're passionate about advancing genetic medicine and thrive in a collaborative environment, this opportunity is perfect for you. Join a dynamic team dedicated to transforming patient care through groundbreaking science and regulatory excellence.

Qualifications

• 12-15 years in Regulatory Affairs CMC or related fields.
• Proven leadership in cross-functional CMC teams.
• Deep understanding of CMC drug development regulations.

Responsibilities

• Develop global regulatory strategies for product submissions.
• Manage CMC aspects and prepare regulatory filings.
• Provide strategic advice to junior team members.

Skills

Regulatory Affairs CMC

Cross-functional Team Leadership

Communication Skills

Project Management

Understanding of CMC Regulations

Education

BA/BS in Life Sciences

Advanced Degree (Preferred)

Tools

Global Dossier Management Systems

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

1. Developing global regulatory strategies and preparing global CMC Regulatory strategy documents for assigned commercial and/or clinical product submissions.
2. Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of BioMarin’s programs; preparing and submitting global regulatory filings including clinical trial and marketing applications, post-approval variations, and license maintenance activities.
3. Conducting risk-based evaluations of proposed manufacturing changes and providing strategic regulatory guidance for their implementation.
4. Researching and interpreting global CMC regulations, providing guidance to Quality, Manufacturing, and Process Development teams.
5. Representing Regulatory Affairs CMC on cross-functional project teams.
6. Managing interactions with global regulatory authorities to ensure acceptance and approval of submissions.
7. Building relationships with colleagues and stakeholders within WWRD and Technical Operations.
8. Providing strategic and tactical advice to junior team members on key projects.
9. Traveling periodically for meetings and conferences.

Experience and Skills

Required:

• 12-15 years of experience in Regulatory Affairs CMC or related fields within the pharmaceutical or biotech industry, with exposure to both development and commercial phases. Experience with combination products is desirable.
• Experience in managing and filing marketing applications, variations, and assessments in multiple regions including US, EU, and Asia Pacific.
• Proven leadership in cross-functional CMC teams.
• Deep understanding of CMC drug development regulations and guidelines.
• Excellent interpersonal and communication skills.
• Ability to work effectively in a matrix environment with cross-functional and international teams.

Desired:

• Experience with US, CA, EU regulatory CMC processes.
• Leadership in authoring documents for initial submissions and approvals.
• Experience with biologics and small molecules.
• Coaching, training, and mentoring skills.
• Proven ability to interact successfully with regulatory authorities.
• Background in chemistry or molecular biology is a plus.

Additional Skills:

• Project management skills are advantageous.
• Experience with device or combination products is a plus.
• Familiarity with global dossier and document management systems.

Education

BA/BS in life sciences, chemistry, molecular biology, or related field is required; an advanced degree is preferred.

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

Equal Opportunity Employer/Veterans/Disabled

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