Moderna is seeking a Sr. Manager of Regulatory Strategy to provide regulatory support for programs within the COVID-19 franchise and to be based in one of Moderna's East Coast hubs. Their support includes but is not limited to managing INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, DSURs, MAA/BLA/NDA, etc.).
Here's What You'll Do:
Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.
Coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, pediatric plans, DSURs, MAA/BLA/NDA, etc.
Identify and assess regulatory risks for assigned projects or programs.
Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate.
Ability to work both independently and within project teams, committees, etc. to achieve group goals.
Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies.
Here's What You'll Bring to the Table:
BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
5+ years of experience in the Pharmaceutical industry preferred
3+ years of experience in Regulatory strategy or relevant training/experience preferred
Experience in Infectious Diseases and/or Biologicals is preferred
Strong knowledge of current US and EU 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--preferably from at least both US and EU
Demonstrate strong organizational skills, including the ability to prioritize workload.
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 in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
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)
