Associate Director, Regulatory Strategy & Global Resilience Initiatives
Associate Director, Regulatory Strategy & Global Resilience Initiatives
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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.
Modernas Project Resilience encompasses the construction and operationalization of in-country pharmaceutical manufacturing sites dedicated to producing commercial mRNA vaccines. The scope of Project Resilience involves constructing facilities that adhere to stringent regulatory standards qualifying the manufacturing processes and equipment to ensure they meet the necessary quality and safety requirements obtaining facility licensure within the region and obtaining the necessary regulatory approvals.
Project Resilience aims to enhance the production capabilities and distribution of mRNA-based therapeutics and vaccines thereby bolstering the resilience of healthcare systems by ensuring direct access to rapid pandemic response capabilities and access to Modernas vaccines in development for critical vaccines and therapeutics.
This role will lead the execution of the regulatory deliverables for Project Resilience across all sites (e.g. UK Canada Australia etc.). This role requires an understanding of the various development and registration activities in the local Resilience countries and awareness of the interdependencies of the Portfolio timelines as well as the Resilience manufacturing site timelines.
Heres What Youll Do:
Your key responsibilities will be:
Contribute to the consolidated regulatory deliverables plan for Project Resilience.
Work closely with the Country Regulatory Leads in the Project Resilience markets to ensure the robustness and timeliness of regulatory plans and the execution and coordination of the overall GRS activities for Project Resilience among GRS line functions at the HQ regional and country levels.
In collaboration with GRS HQ and Country Regulatory Leads identify and assess Project Resilience regulatory risks coordinate and prepare risk register potential delays and corresponding mitigation plans.
Coordinate regulatory activities with external partners and stakeholders ensuring alignment and compliance with local and international regulations.
Assist in preparation of regulatory documents and applications to Health Authorities ensuring accuracy completeness and timeliness.
Your responsibilities will also include:
Provide timeline updates to GRS LT and raise Project Resilience topics relevant for endorsement discussion or decision.
Prepare and deliver effective communications and presentations for external and internal audiences.
Integrate and manage the UK-specific aspects of the role ensuring 40-50% of the responsibilities are focused on UK-specific regulatory activities and 50% on the integration of Resilience sites to consolidate best practices and processes.
Mentor and guide junior regulatory staff fostering a collaborative and high-performance culture within the regulatory team.
Monitor regulatory developments and trends that may impact Project Resilience advising on necessary adjustments to strategies and plans.
Ensure all regulatory activities are conducted in accordance with Modernas policies SOPs and ethical standards.
The key Moderna Mindsets youll need to succeed in the role:
Prioritize the platform: Ensuring that the strategic goals of Project Resilience align with the overarching objectives of Modernas platform.
Act with urgency: Rapidly addressing regulatory challenges and making swift decisions to keep Project Resilience on track.
Heres What Youll Bring to the Table:
Degree in Life Sciences or related discipline advanced degree preferred (PharmD MSc PhD).
8 years of experience in the pharmaceutical industry; 5 years of experience in Global Regulatory CMC strategy.
Good knowledge of current international regulations related to GMP manufacturing licensing and overall quality principles for innovative medicines including mRNA technology and gene therapy requirements.
Experience and good understanding of Module 3 content of regulatory submissions.
Experience with manufacturing process tech transfers and registration of new manufacturing sites.
Strong project management and analytical skills.
Ability to bring together various stakeholders and to reconcile different perspectives and priorities.
Ability to work independently to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate in a dynamic cross-functional matrix environment to drive meeting each programs 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.
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:
Exec
Employment Type
Full-Time
