Manager, Regulatory Strategy, International
vor 2 Wochen
**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 is expanding its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
Moderna is seeking a forward-thinking and agile Manager, Regulatory Strategy, International, based in Basel, Switzerland, to provide vital regulatory support in the dynamic field of messenger RNA therapeutics. This role reports to the Senior Director, Regulatory Affairs Strategy, Infectious Disease, and plays a key role in interfacing with Health Agencies in EU and International markets.
Within 3 Months you will...
Begin collaborating with the Senior Director, Project teams, RA International team, and International Reg-CMC to develop and execute regulatory strategy.
Within 6 Months you will...
Identify and assess regulatory risks for assigned projects, maintaining communication with relevant regulatory agencies.
Within 12 Months you will
Be responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.
Ensure tracking, follow-up, and archiving of correspondence, regulatory commitments, and queries from International Health Agencies.
**Here’s What You’ll Bring to the Table**:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy
Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
Strong experience with CTD format and content regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
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 program’s critical regulatory milestones
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
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.
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
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