Moderna, Inc. is seeking a Director of Regulatory Strategy to support INT within the Oncology programs. 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 oncology products as unprecedented new drug modality in the U.S. and other markets. The Director will be a strategic leader within Global Regulatory Science, 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. Prior regulatory experience with Oncology development preferred.
Here's What You'll Do:
Serve as 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 the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate.
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.
Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management of submissions to Health Agencies.
Sets strategic direction and leads the development of 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 and nonclinical development processes.
Monitors regulatory developments related to mRNA platform and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes.
Establishes and maintains excellent relationships with regulatory agency personnel.
Negotiates directly and effectively with health agencies regarding company's filings. Responds to requests for additional data, organizes and manages participation in meetings.
Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
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.
Serves as regulatory science representative to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet.
Identifies areas in need of improvement and lead the development and implementation of process improvements
Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments.
Manages resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
Here's What You'll Bring to the Table:
BA/BS degree in a scientific/engineering discipline required. PharmD, Masters or PhD preferred.
10+ years of experience in the Pharmaceutical industry
8+ years of experience in Regulatory strategy, including specifically: Oncology Development
Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs.
Strong experience with CTD format and content regulatory filings
Experience with developing and implementing competitive regulatory strategies
Demonstrated track record in securing product approvals and maintaining a complex portfolio is preferred
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 across therapeutic areas including Oncology development is preferable.
Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
Ability to work independently to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones.
Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, the Project Team and senior management, as relevant.
Identify areas in need of improvement and lead the development and implementation of process improvements.
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
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 year-end shutdown • 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!
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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/AAP Employer)
