Associate Director, Global Regulatory Science, CMC

Moderna Inc.; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Annual discretionary bonus/equity

In-office collaboration culture

Job summary

Moderna Inc. is seeking an Associate Director, Global Regulatory Affairs, CMC to oversee CMC and Quality related agency correspondence and regulatory submissions, focusing on LATAM regulatory needs.

You will lead regulatory activities, ensure high-quality CMC sections, and guide cross-functional teams in vaccine, oncology, and rare disease programs in a fast-paced environment.

Qualifications

• Regulatory CMC knowledge across LATAM
• Experience with CTD format and CMC content
• Strong written and oral communication
• Regulatory strategy development for post-approval submissions
• Regulatory guidance to manufacturing and quality teams
• Knowledge of cGMP and health authority expectations

Responsibilities

• Develop and implement CMC regulatory strategies for LATAM submissions
• Provide guidance on regulatory CMC aspects of product development
• Review documents for submission readiness to health authorities
• Lead regulatory CMC discussions with health authorities
• Develop and maintain CMC submission templates and processes
• Advise manufacturing and quality teams on CMC changes and controls
• Interpret regulatory guidance and apply it to internal programs
• Manage multiple programs across vaccines, oncology and rare diseases

Skills

CMC Regulatory

Regulatory Strategy

Regulatory Writing

Cross-functional Collaboration

Regulatory Submissions

Communication Skills

Education

BS in Pharmaceutics/Chemistry/Chemical Engineering

MS in related field (desirable)

Job description

The Role

Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products, with focus on Latin America (LATAM). The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.

Here’s What You’ll Do

• Develop and implement effective CMC regulatory strategies for post-approval submissions in LATAM and identify regulatory risks.
• Provide guidance on regulatory CMC aspects of product development projects.
• Review documents for submission readiness, ensuring conformity to health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
• Develop regulatory processes and procedures to support the CMC components of regulatory submissions.
• Support the creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Offer interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).

The key Moderna Mindsets you’ll need to succeed in the role

• Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
• Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.

Here’s What You’ll Need (Basic Qualifications)

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
• 8+ years of experience in Biologics focused Regulatory CMC
• Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
• Strong knowledge of current LATAM regulations
• Strong knowledge of cGMP
• Strong experience with CTD format and CMC content of regulatory filings
• Exceptional written and oral communication

Our Working Model

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.

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

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

Equal Opportunities

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 a place where everyone can grow. Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

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 [e-mail] .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.