Director/Associate Director, CMC Regulatory Affairs
The Director/Associate Director, CMC Regulatory Affairs will be based at the Cambridge and/or Norwood, MA sites and will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead and 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.
Here's What You'll Do:
- Develop/implement 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
- Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Develop 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 manufacturing and 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
- Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)
Here's What You'll Bring to the Table:
- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
- 10-15 years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 10+ years of experience in Biologics focused Regulatory CMC
- Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
- Strong knowledge of current US, EU and ROW regulations
- Strong knowledge of cGMP
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan and tuition reimbursement program.
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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.