Director, Regulatory Strategy, Infectious Disease, Next Generation COVID 19 Vaccine at ModernaTX, Inc. in Bethesda, Maryland

Job Description:

The Role:



Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for Moderna's next generation COVID-19 messenger RNA (mRNA) vaccines to be based in one of Moderna's East Coast hubs. This is a role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of mRNA vaccines. The Director will be a strategic leader within Global Regulatory Science, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. Prior regulatory experience with infectious disease & vaccine development preferred.



Here's What You'll Do:

• Serve as global regulatory lead accountable for all regulatory aspects of next generation COVID-19 mRNA vaccines, including development and implementation of the global regulatory strategy and plans.
  
  


• Advises project teams regarding the development and implementation of regulatory strategy through all stages of the product's development lifecycle.
  
  


• Ensure the global regulatory strategy for assigned project(s) is aligned with the business objectives and have been negotiated with relevant health authorities as appropriate.
  
  


• Ensures regulatory risk assessment and mitigation plans are developed and aligned across functions.
  
  


• Sets strategic direction and overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities for assigned program(s).
  
  


• Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.
  
  


• Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.
  
  


• Reviews and approves regulatory documents and dossiers prior to submission to regulatory authorities.
  
  


• Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet for assigned program(s).
  
  


• Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicates potential impact to internal teams.
  
  


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


• Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
  
  

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

• BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.
  
  


• 10+ years of experience in the Pharmaceutical industry
  
  


• 6+ years of experience in Regulatory strategy, including specifically: Vaccine Development
  
  


• Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Infectious Disease vaccine programs.
  
  


• Strong experience with CTD format and content regulatory filings
  
  


• Experience with developing and implementing competitive regulatory strategies
  
  


• Demonstrated track record in securing product approvals and maintaining a complex portfolio
  
  


• 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
  
  


• Direct experience of leading regulatory authority meetings in different phases of drug development
  
  


• Regulatory knowledge across therapeutic areas including infectious diseases and vaccine development is preferable.
  
  


• Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
  
  


• Ability to work independently to manage multiple projects in a fast-paced environment.
  
  


• Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones.
  
  


• Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
  
  


• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, the Project Team and senior management, as relevant.
  
  


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


• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
  
  

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)


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