Sr. Manager, Regulatory Strategy - Moderna, Inc.

The Role:

Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager will provide regulatory support for Oncology. Their support includes but is not limited to managing the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)

Heres What Youll Do:

• Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)

• Works with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.

• Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.

• Contact regulatory agencies relevant to assigned projects or programs, as appropriate.

• Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).

• Contribute, maintain the Core Data Sheet and support global labeling team meetings.

• Ability to work both independently and within project teams, committees, etc. to achieve group goals.

Heres What Youll Be Doing:

• 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 Oncology is strongly preferred

• Strong knowledge of current US and EU regulations

• Strong experience with CTD format and content of regulatory filings

• Exceptional written and oral communication

• Experience with developing and implementing gap analysis and related competitive regulatory strategies

• 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 major regulatory submissions and supportive amendments or supplements.

• Knowledge and understanding of applicable regulations.

• Experience in interpretation of regulations, guidelines, policy statements, etc.

• Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description. Base compensation for these positions in Washington State range from $125,500 to $201,000. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills. Compensation decisions are made on the facts and circumstances of each case.

In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, paid family leave offerings, including at least 18 weeks of 100% paid parental leave, lifestyle spending account, adoption, surrogacy, and family-planning benefits, generous paid time off, including:

Vacation, sick time, and observed Company-wide holidays

Paid volunteer time to participate within your community

Discretionary winter holiday shut down

Paid 4-week sabbatical after 5 years, and every 3 years after

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, theinfrastructure 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 peopleare 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. Were 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)

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