The Senior Director, CMC Regulatory Affairs will be based at the Norwood or Cambridge, MA site and will be responsible for managing a team of CMC experts that prepare and overseeing 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. RegCMC strategy development to align with the needs of the company, the regulators and the patients will be a key component.
Heres What Youll 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 need 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 manufacturingand 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
Heres What Youll Bring to the Table:
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
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
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 winter shut down
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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.