Director, Regional Regulatory Strategy, Infectious Diseases

Moderna

Basel, Switzerland

The Role:

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.

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