Associate Director, Global Regulatory Strategy, Infectious Disease, COVID 19 Vaccine

The Role:

Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the COVID-19 franchise to be based in one of Moderna’s US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in gaining and maintaining market approval for messenger RNA vaccines as unprecedented new drug modality in the US and other markets as relevant.

The Associate Director will be a strategic leader within the Global Regulatory Strategy, Infectious Diseases group. They will be responsible for developing and executing regulatory plans for at least the US market for assigned programs at any stage of product development. As an expert within Regulatory, they will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate.  Prior regulatory experience with infectious disease & vaccine development preferred.

Here’s What You’ll Do:

• Sets strategic direction for at least the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned program(s).

• Ensures the US regulatory strategy is aligned with the global strategy for assigned program, including for initial marketing application submissions and/or vaccine strain updates. 

• Leads the development of content, format and accountability for regulatory submissions and related supplements and amendments to at least the US FDA, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, (s)BLA, etc.

• Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to new government/regulatory developments.

• Responds to requests for additional data, organizes and manages participation in meetings relevant to at least the US market.

• Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).

• Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.

• May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.

• Identify areas in need of improvement and lead the development and implementation of process improvements.

Here’s What You’ll Bring to the Table:

• BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.

• 7+ years of experience in the Pharmaceutical industry preferred

• 5+ 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 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 at least in the US

• 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 across all stages of product development.

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 offeri