Senior Submission Manager, Regulatory Operations

The Role:

The Sr Mgr, in collaboration with the Regulatory Lead, plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Sr Mgr provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions. The Sr Mgr will also support the Director of Regulatory Operations, or other members of the Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions, and lessons learned dissemination, and will assist in other activities as needed. It is expected that Mgr/Sr Mgr, will be deeply involved in publishing and submission management and will contribute to archiving and information management activities of the RA Department, along with implementation of systems and tools.

Heres What Youll Do:

• Assists in strategic planning activities and translation of strategic decisions into operational plans related to all areas of regulatory operations.

• In collaboration with the Regulatory Lead, manages the development and maintenance of a global submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.

• As a global submissions expert, ensures the project team has awareness and knowledge of esubmissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

• Provides operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.

• Has a leading role in development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities

• Manages activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.

• Maintains technical expertise of regulatory requirements and ensures alignment with company processes and client requirements

• Acts as a subject matter expert, and system administrator, for Moderna document management system.

• Compiles regulatory submissions for assigned submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.

• Leads and manages special projects and teams as needed.

Heres What Youll Bring to the Table:

• Candidates will preferably possess a Bachelors degree in a scientific discipline or systems technology (or equivalent)

• In addition to this education requirement, we also require at least 6 years of pharmaceutical experience working in a regulated, life science (with 2+ years in a management role in a pharmaceutical, biotechnology, consumer health environment)

• In lieu of a Bachelors degree, we can consider candidates on the proviso that they possess at least 10 years' experience in supporting Regulatory submissions (and with a demonstrable track record of planning / preparing high quality global submissions)

• Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools

• Extensive knowledge of North American/Global submission standards (FDA, Health

• Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)

• Knowledge of CDISC (ADaM, SEND, SDTM)

• A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)

• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.

• MS PowerPoint skills

• 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, 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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