Associate Director, Regulatory Project Management – Global Regulatory CMC

The Role:

We are seeking an experienced and dynamic Associate Director of Regulatory CMC Project Management to join our team. In this leadership role, you will manage and oversee regulatory projects related to Chemistry, Manufacturing, and Controls (CMC) for the development and commercialization of biopharmaceuticals, biologics, or small molecules. You will lead cross-functional teams to ensure timely, high-quality regulatory submissions and approvals, manage project timelines, and ensure compliance with global regulatory requirements.

The ideal candidate will have a strong background in CMC regulatory affairs, project management, and a deep understanding of global regulatory frameworks (FDA, EMA, ICH, etc.). You will be instrumental in supporting the launch of innovative therapies and ensuring that they meet both internal and regulatory standards across multiple markets.

Here’s What You’ll Do:

Leadership & Strategic Project Management:

• Lead and oversee the strategic management of CMC regulatory projects for drug development programs (small molecules, biologics, or biosimilars).

• Develop and implement regulatory CMC strategies for drug candidates in alignment with product development timelines and company goals.

• Ensure the successful execution of regulatory submission milestones for CMC documentation, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and variations.

• Manage a team of regulatory professionals, providing mentorship and guidance on CMC regulatory matters.

Regulatory Submissions & Documentation:

• Oversee the preparation, review, and submission of CMC sections for regulatory filings (IND, CTA, NDA, MAA, BLA, etc.) in compliance with global regulatory requirements and support the integration of project plans

• Ensure the CMC submission package is scientifically sound, complete, and aligned with health authority expectations.

• Review and provide input on technical and regulatory CMC content prepared by internal teams or contract manufacturers.

• Coordinate regulatory responses to Health Authority inquiries related to CMC filings and act as a liaison for regulatory agency meetings.

Cross-Functional Team Leadership:

• Collaborate closely with R&D, Manufacturing, Quality, Clinical, and Commercial teams to ensure regulatory CMC deliverables are aligned with product development timelines.

• Provide regulatory expertise and advice to internal stakeholders to mitigate risks and resolve issues related to CMC regulatory filings.

• Facilitate effective communication across functional teams to ensure consistency in regulatory submissions and approvals.

Regulatory Strategy & Compliance:

• Develop and implement global regulatory strategies for CMC that support the product’s lifecycle, from development through commercialization.

• Ensure regulatory compliance with local and international regulatory guidelines, such as ICH, FDA, EMA, PMDA, and others.

• Monitor regulatory trends, guidance updates, and CMC regulatory best practices to inform and adjust strategies as needed.

Project and Risk Management:

• Oversee the planning, tracking, and execution of CMC regulatory project timelines, identifying and mitigating potential risks that may impact project deliverables.

• Lead efforts to streamline regulatory CMC processes and ensure effective coordination between teams and external partners.

• Ensure the timely resolution of CMC regulatory issues, including the preparation of risk assessments and contingency plans.

Regulatory Intelligence & Training:

• Maintain up-to-date knowledge of regulatory guidelines, CMC-related regulations, and health authority requirements globally.

• Contribute to the development and dissemination of CMC regulatory intelligence within the organization.

• Provide training and development opportunities for junior regulatory staff on CMC regulatory matters and best practices.

External Collaboration and Representation:

• Represent the company at meetings with regulatory agencies (FDA, EMA, Health Canada, etc.) to discuss CMC-related submissions and issues.

• Foster relationships with key external stakeholders, including regulatory agencies, contract manufacturers, and consultants, to ensure successful collaboration.

• Coordinate and manage external consultants or vendors providing CMC regulatory expertise, when needed.

Here’s What You’ll Bring to the Table:

Education:

• Bachelor’s degree in life sciences, chemistry, pharmacy, biochemistry, or a related field; a Master’s or PhD is preferred.

• Additional certification in regulatory affairs (e.g., RAC – Regulatory Affairs Certification) is a plus.

Experience:

• Minimum of 8 years of experience in Regulatory Affairs/ or Project Management with a focus on CMC, and at least 5 years in a project management role.

• Experience with regulatory submissions for biologics, biosimilars, or small molecules (IND, NDA, MAA, BLA, variations, etc.) is essential.

• Strong understanding of CMC-related regulatory requirements across major global markets (FDA, EMA, ICH, etc.).

• Previous experience in managing cross-functional teams and leading complex projects with global scope.

Skills & Competencies:

• Strong leadership skills with experience managing cross-functional teams in a regulatory setting.

• Excellent project management skills, with a proven ability to deliver projects on time, within scope, and within budget.

• In-depth knowledge of CMC regulations, good manufacturing practices (GMP), and quality systems.

• Ability to navigate and resolve complex regulatory challenges, particularly related to CMC issues.

• Strong written and verbal communication skills, with the ability to effectively present complex regulatory information to internal and external stakeholders.

• Detail-oriented with strong organizational and multitasking capabilities.

• Ability to manage multiple projects simultaneously, ensuring strategic alignment and delivery within scope and deadlines.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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