Sr. Manager, Global Regulatory Strategy, Infectious Dieases, COVID 19

The Role:

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 o