Manager, Regulatory Science, EEMEA
Manager, Regulatory Science, EEMEA
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Job Description
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.
Modernas 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 solidifying its presence in London a global hub for scientific research and innovation. Our London office focuses on commercial operations ensuring the delivery of our revolutionary products to the UK market. Were seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.
In this role you will be instrumental in shaping and driving regulatory strategies for the Eastern Europe Middle East and Africa (EEMEA) region. You will partner closely with the Director of Regulatory Affairs EEMEA global regulatory teams and cross-functional stakeholders to ensure smooth regulatory execution across Modernas pipeline and marketed products. This is a unique opportunity to work with Health Authorities across diverse markets supporting both early development and lifecycle management of mRNA medicines. You will act as a trusted regulatory advisor managing submissions post-approval activities and risk assessment while representing Modernas pioneering science externally. By combining strong technical knowledge with collaboration you will help Moderna navigate complex regulatory pathways and deliver on its mission of transforming patient outcomes. This is an individual contributor role based in London with a remit spanning the EEMEA region.
Heres What Youll Do:
Your key responsibilities will be:
Lead regulatory aspects of assigned projects and programs across EEMEA.
Support the Director Head of Regulatory Affairs EEMEA Global Regulatory Teams and Regional/Country Cross-Functional Teams in developing and executing regulatory strategies.
Contribute to and oversee the preparation of regulatory submissions including dossiers meeting requests orphan-drug designations priority review applications safety reports and RTQs.
Manage post-approval lifecycle activities and commitments of approved products in EEMEA.
Your responsibilities will also include:
Anticipating and addressing regulatory challenges associated with mRNA as a new drug modality.
Maintaining close contact with Health Authorities and partner regulatory teams/consultants.
Identifying and assessing regulatory risks for assigned programs.
Preparing and delivering effective communications and presentations for internal and external stakeholders.
Providing cross-functional regulatory guidance across Modernas business activities from IND through lifecycle management.
The key Moderna Mindsets youll need to succeed in the role:
We obsess over learning. We dont have to be the smartest we have to learn the fastest. Regulatory science in EEMEA requires agility and constant learning to adapt to evolving frameworks and diverse authority expectations.
We act with urgency; Action today compounds the lives saved tomorrow. Timely proactive regulatory engagement is critical to accelerating access to Modernas transformative mRNA medicines for patients across EEMEA.
Heres What Youll Bring to the Table:
BA/BS degree in a scientific major (eg. Biology Biochemical Bioengineering Pharmacy) required.
10 years of experience in the Pharmaceutical industry
7 years of experience in Regulatory Affairs
Strong knowledge of current EEMEA and International regulations including the US and the EU related to the clinical nonclinical and CMC development of biologic products
Strong experience with CTD format and content of regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration line extension and license maintenance in EEMEA
Able to help create and maintain parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information
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 programs critical regulatory milestones
Able to effectively communicate the regulatory strategy risks mitigation and overall plans to Project Teams and senior management as relevant
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Business level fluency in English is required. Fluency in Arabic is an advantage.
A desire to be part of a high-growth transformational company that is Bold Relentless Curious and Collaborative
At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.
- 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 global recharge days and a discretionary year-end shutdown
- Savingsandinvestments
- 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 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 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 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 committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons 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. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at .
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Required Experience:
Manager
Employment Type
Full-Time
