The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna's strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility, part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all.
As the Director, Regional Regulatory Strategy for Infectious Diseases at Moderna, you will lead regulatory strategies with the EMA and international agencies for mRNA therapeutics, managing regulatory interactions and marketing authorizations across the EU and other global markets. Your role involves close collaboration with global teams for integrated planning and serving as the primary contact for regional health authorities. You will oversee regulatory submissions, ensure compliance with regional requirements, and provide expert advice on regional regulatory specifics. Additionally, you will mentor a team of regulatory affairs professionals and navigate the unique challenges of novel drug modalities in infectious diseases.
Here's What Youll Do:
Within 3 Months, You Will…
Acquire an in-depth understanding of Moderna's innovative approach in using mRNA technology for therapeutic applications, focusing on the infectious diseases portfolio.
Initiate the development of regulatory strategies tailored to the EU and international markets, ensuring alignment with Moderna's global objectives and the unique aspects of mRNA therapeutics.
Engage in preliminary discussions with the European Medicines Agency (EMA) and other relevant health authorities to establish a foundation for future regulatory interactions.
Begin active collaboration with internal teams, including Clinical Development, Medical Affairs, and Pharmacovigilance, to align on cohesive and integrated regulatory strategies.
Within 6 Months, You Will…
Lead the preparation and submission of key regulatory documents within the region, including INDs, CTAs, MAAs, and health authority queries, ensuring compliance with regional guidelines.
Foster and strengthen relationships with regional health authorities, becoming the primary regulatory contact for Moderna in these regions, and establishing a framework for ongoing positive interactions.
Systematically analyze and interpret regulatory trends and changes in the EU, Asia-Pacific, and Latin America, advising internal teams on potential impacts and strategic responses.
Coordinate with cross-functional teams to ensure that regional regulatory considerations are seamlessly integrated into Moderna’s overarching regulatory plan and product strategy.
Within 12 Months, You Will…
Drive and oversee major regulatory initiatives and submissions, demonstrating success in navigating the regulatory landscape and achieving key milestones.
Assume full responsibility for mentoring and managing the regulatory affairs team within the region, fostering professional development and high-performance standards.
Establish yourself as a key contributor in shaping Moderna’s regulatory strategies and presence in the infectious diseases therapeutic area, influencing regional and global regulatory approaches.
Ensure that Moderna's regulatory strategies in the region are effectively adapted to support the dynamic and evolving landscape of mRNA-based therapeutics in infectious diseases.
Here’s What You’ll Bring to the Table:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (e.g., PharmD, MSc, PhD) is preferred.
Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regional strategy.
Demonstrated success in leading regulatory submissions and health authority interactions.
Comprehensive knowledge of the regulatory environment and guidelines in key regions, including the EU, Asia-Pacific, and Latin America.
Experience in leading and developing teams with strong leadership and interpersonal skills.
Excellent communication abilities, with fluency in English; additional language skills are beneficial.
Strategic thinker with the ability to operate effectively in a fast-paced, global environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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