Associate Director, Global Regulatory, CMC

BioSpace; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare benefits

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna, in the United States, seeks an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global strategies, and guide product teams toward compliant submissions.

You will lead interactions with health authorities, review submission-readiness documents, manage multiple projects in a fast, results-oriented environment, and contribute to bringing transformative medicines to patients.

Qualifications

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 5+ years of experience in Biologics focused Regulatory CMC.
• Strong knowledge of current Global CMC regulations, including CTD format and content of CMC regulatory submissions.
• Knowledge of regulatory procedures and legislation related to CMC for drug development, product registration, line extension and license maintenance.

Responsibilities

• Develop/implement effective CMC regulatory strategies for global submissions (IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness to ensure conforming submissions.
• Lead Regulatory CMC discussions with health authorities to facilitate review and approval of submissions.
• Perform assessment of manufacturing change controls.
• Support development of regulatory processes and procedures to support CMC components of regulatory submissions.
• Support creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Provide interpretation of regulatory guidance documents and regulations and advise teams on applicability.

Skills

Regulatory CMC

Global submissions

Cross-functional collaboration

Regulatory guidance

Education

BS/MS/PhD in Molecular Biology/Pharmaceutics/Chemistry/Chemical Engineering

Job description

The Role

The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The individual will be expected to provide guidance to the product teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.

Here’s What You’ll Do

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Perform assessment of manufacturing change controls
• Support development of regulatory processes and procedures to support CMC components of regulatory submissions
• Support the creation and maintenance of CMC submission templates
• Provides CMC regulatory guidance to manufacturingand quality teams; evaluates CMC change controls
• Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

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

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required
• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
• 5+ years of experience in Biologics focused Regulatory CMC
• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
• Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
• Ability to work independently
• Exceptional written and oral communication
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Pay & Benefits

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

• 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.

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.

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.