The Manager of CMC Regulatory Science will be based in Norwood, MA and will be responsible for advising, preparing, and overseeing CMC and Quality related strategies compliant and optimized for the United States. The Manager of Regulatory Science CMC will support Reg-CMC correspondence and regulatory applications, as well as support CMC submissions and regulatory compliance for the global development of the Moderna platform. This position will support all regulatory activities to provide high quality CMC sections of regulatory documentation. 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.
Heres What Youll Do:
Support effective CMC regulatory strategies for 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
Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
Support 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
Heres What Youll Bring to the Table:
MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
6+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
3+ years of experience in focused Regulatory CMC, preferably Biologics based
Strong knowledge of current regulations related to the clinical, nonclinical, and CMC development
Strong experience with CTD format and content regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each programs critical regulatory milestones
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
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.