The Role
Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Moderna’s US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.
The Associate Director will be a strategic leader within the Global Regulatory Strategy, Oncology group. They will be responsible for developing and executing regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development. They will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is strongly desired.
Here’s What You’ll Do
- Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL
- Sets strategic direction for the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned programs.
- Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
- Leads the strategy for US FDA interactions with the cross functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
- Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements.
- In collaboration with the cross functional team, leads the response to health authority requests for additional data, organizes and manages participation in meetings relevant to aspects of compound development
- Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).
- Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.
- May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.
- Identify areas in need of improvement and lead the development and implementation of process improvements.
Here’s What You’ll Bring To The Table
- BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred
- 7+ years of experience in the Pharmaceutical industry preferred
- 5+ years of experience in Regulatory strategy or relevant training/experience preferred
- Experience in oncology therapeutics highly preferred
- Demonstrated track record in being a leader on functional and cross-functional teams
- Strong knowledge of current US regulations and knowledge of ex-US regulations
- Strong experience with CTD format and content of regulatory filings
- Exceptional written and oral communication
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US
- Demonstrate strong organizational skills, including the ability to prioritize workload.
- Experience in developing regulatory strategies at various drug development time points
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- Experience in authoring regulatory documents
- Knowledge and understanding of applicable regulations.
- Experience working on products across all stages of product development.
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
- Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
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 leavesandaccommodations@modernatx.com. (EEO Employer)
