Senior Manager, Regulatory Project Management, Global Regulatory CMC

The Role

We are seeking an experienced and dynamic Regulatory CMC Project Senior Manager to join our team. In this role, you will manage regulatory submissions 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, and manage project timelines and submission-related processes.

The ideal candidate will have a strong background in CMC regulatory submissions, project management, and a deep understanding of global regulatory submission 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

• Regulatory CMC Project Management:
• Lead and oversee the tactical management of CMC regulatory submissions for assigned drug development programs.
• Ensure the successful execution of regulatory submission milestones for CMC documentation, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), Marketing Authorization Applications (MAA), and variations.
• Regulatory Submissions & Documentation:
• Manage 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.
• Coordinate regulatory responses to Health Authority inquiries related to CMC filings.
• Cross-Functional Team Leadership:
• Collaborate closely with Reg CMC and Technical Development to ensure regulatory CMC deliverables are aligned with product development and submission timelines.
• Facilitate effective communication across functional teams to ensure consistency in regulatory submissions and approvals.
• 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.
• Manage efforts to streamline regulatory CMC processes and ensure effective coordination between teams and external partners.
• Coordinate 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.
• Provide training and development opportunities for junior regulatory staff on CMC regulatory submission matters and best practices.
  
  

Here’s What You’ll Bring To The Table

• Education:
• Bachelor’s degree in life sciences, chemistry, pharmacy, biochemistry, or a related field;
• 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 processes for submissions within cross-functional teams and leading complex projects with global scope.
• Skills & Competencies:
• Strong submission 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.
  
  

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements.

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 Employer) 

Moderna is a biopharmaceutical company that focuses on the development and commercialization of mRNA-based therapeutics and vaccines. The company was founded in 2010 and is headquartered in Cambridge, Massachusetts.