Sr. Manager/Assoc. Director, Regulatory Strategy, Infectious Disease
Moderna Therapeutics is seeking a Sr. Manager/Assoc. Director of Regulatory Strategy to support infectious disease programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager/Assoc. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.
Here's What You'll Do:
- Develops content, format and accountability for regulatory submissions and related supplements and amendments.
- Advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
- Establishes and maintains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings.
- Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory agencies.
- Serve as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project
- Represent Regulatory Affairs on cross-functional project teams
- Ensure alignment of regulatory strategy and plan on a continuous basis within the Moderna ecosystem.
Here's What You'll Bring to the Table:
- BA/BS degree in a scientific/engineering discipline required, Masters or PhD preferred.
- 10+ years of experience in the Pharmaceutical industry
- 6+ years of experience in Regulatory strategy, including specifically: Infectious Disease
- Strong knowledge of current US and EU regulations, including vaccine regulatory pathways.
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
- Direct experience of leading regulatory authority meetings in different phases of drug development
- Regulatory knowledge in a number of therapeutic areas would be highly valuable.
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.