Sr. Director, Regulatory Strategy - Infectious Diseases, COVID-19 Franchise
- Employer
- Moderna, Inc.
- Location
- Bethesda - USA - MD
- Start date
- Aug 29, 2024
View more categoriesView less categories
- Discipline
- Marketing, Science/R&D, Infectious Disease, Pathology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
The Role:
Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy for the COVID-19 franchise to be based in its Cambridge headquarters or one of Modernas East Coast hubs. This role is 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 messenger RNA COVID-19 vaccines. The Sr. Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for programs within the assigned franchise, 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 Youll Do:
Serve as overall global regulatory lead accountable for all regulatory aspects of the COVID-19 franchise, including development and implementation of the global regulatory strategy and plans for programs within the franchise.
Advises project teams regarding the development and implementation of regulatory strategy throughout each programs life cycle .
Ensures delivery of activities essential to maintain regulatory compliance and license to operate in countries worldwide where mRNA COVID-19 vaccines are authorized or licensed.
Ensures regulatory commitments are managed and addressed in a compliant, timely and high quality manner.
Ensures alignment of regulatory activities with franchise priorities, alignment of regulatory risk mitigation plans across relevant sub-functions, and shared ownership of regulatory deliverables
Overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities.
Responsible for ensuring regulatory risks, mitigation and contingency plans are aligned within the function prior to governance.
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.
Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.
Establishes and maintains excellent relationships with global health agencies.
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 dossier content prior to submission to regulatory authorities.
Serves as regulatory affairs executive to provide input on 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
Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
Manages a team of Regulatory strategists that are responsible for the portfolio deliverables and act as Global Regulatory leads or delegates for specific programs
Heres What Youll Bring to the Table:
BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.
12+ years of experience in the Pharmaceutical industry
8+ 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 effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each programs 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.
May be responsible for line management and development of direct reports.
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, 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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Company
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
Stock Symbol:
MRNA
Stock Exchange:
USNASDAQ GS
- Website
- https://modernatx.com/
- Phone
- 617-714-6500
- Location
-
200 Technology Square
Cambridge, MA
US
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