Executive Director, CMC Regulatory Science

Moderna; Norwood (MA); On-site; USD 224,900 - 404,600; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic well-being approach

Generous paid time off

Savings and investment opportunities

Job summary

Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates will have over 10 years in the pharma/biotech industry, with strong knowledge of US and international regulations. The position offers a competitive salary range of $224,900 - $404,600, along with excellent benefits for a holistic approach to employee well-being.

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry.
• 8+ years of experience in Regulatory CMC including DMF/ASMF submissions.
• Strong knowledge of current US, EU, and ROW regulations.
• Strong experience with CTD format and content.

Responsibilities

• Lead a team to develop regulatory strategies for submissions.
• Review documents for submission-readiness.
• Develop regulatory processes to support CMC submissions.
• Interface with health authorities for review and approval.

Skills

Regulatory CMC expertise

Excellent communication

Regulatory strategy development

Team leadership

Education

MS/PhD degree in a scientific/engineering discipline

MS/PhD in Molecular Biology, Pharmaceutics, Chemistry

Job description

The Role

The individual in this position will be based at Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. Additionally, interfacing with the leadership in our departments and assuring clear communication of regulatory topics is critical. Reg CMC strategy development to align with the needs of the company, the regulators and the patients will be a key component.

Here’s What You’ll Do

• Lead a team to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide expertise for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the needs of the company
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level
• Develop regulatory processes and procedures to support CMC components of regulatory submissions
• Support the creation and maintenance of CMC submission templates
• Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls
• Provides interpretation of domestic and international regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully

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

• MS/PhD degree in a scientific/engineering discipline
• 10+ years of experience in the pharmaceutical/biotech industry
• 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions
• Strong knowledge of current US, EU, and ROW regulations
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication

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

• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, 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

Pay & Benefits

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $224,900.00 - $404,600.00. 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.

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. 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 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. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license.