As the Director of Regulatory Projects, you will provide forward-thinking leadership in overseeing strategic and operational aspects of regulatory projects across the organization. You will play a critical role as a strategic partner, guiding the development and execution of global regulatory plans that align with long-term business goals. You will lead cross-functional teams, make progressive and decisive decisions, and identify innovative pathways to ensure the successful delivery of submissions and risk profiles for late-stage programs.
In this role, you will be hands-on in the day-to-day management of projects while maintaining a broader view of the strategic picture. Your proactive planning and decisive leadership will drive continuous improvement and ensure that regulatory initiatives meet both immediate needs and future objectives.
Here's What You'll Do
Act as a forward-thinker and strategic partner in the development and implementation of comprehensive global regulatory plans that align with broader organizational objectives.
Identify innovative pathways and solutions to overcome regulatory challenges and streamline submission processes.
Lead and guide cross-functional teams to ensure the successful execution of regulatory submissions, meeting key milestones, timelines, and strategic goals.
Collaborate closely with senior leadership to provide forward-looking insights, ensuring that all regulatory projects are aligned with the company's long-term vision.
Drive continuous process improvements that enhance both the productivity and strategic alignment of regulatory operations.
Strategic partners to Global Regulatory Lead(s) and Country Regulatory Leads to drive sub-team meetings (team alignments, strategy overview, and decision making)
Make progressive, decisive decisions to resolve complex regulatory challenges, providing innovative solutions to remove obstacles and delays.
Provide regular updates on project/submission/portfolio performance through dashboards and reports, ensuring senior management remains informed of both operational details and the broader strategic impact.
Support and implement risk mitigation strategies to ensure compliance with both internal and external regulatory requirements.
Here's What You'll Need (Basic Qualifications)
Bachelor's degree with 7+ years of experience leading regulatory submissions and or strong program management experience in a hands-on and strategic capacity.
Proven ability to act as a forward-thinking leader, capable of planning ahead and identifying strategic pathways in regulatory operations.
Extensive cross-functional project management experience, with a track record of making progressive and impactful decisions.
Strong understanding of drug development, clinical study processes, and regulatory submissions, with the ability to address both the day-to-day and long-term strategic aspects.
Expertise in ensuring compliance with cGMP and managing complex regulatory submissions across global markets.
Demonstrated ability to lead teams effectively, manage multiple complex projects simultaneously, and contribute to the broader strategic direction of the organization.
This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
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)
