Director, Regional Regulatory Strategy, Infectious
hace 2 semanas
**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 Madrid, a city that thrives on creativity and innovation. As a crucial part of our commercial operations outside the United States, our Madrid office focuses on delivering our groundbreaking products to the Spanish market. We're seeking professionals who are ready to contribute to our mission and shape the future of mRNA medicines in Spain.
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
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
Li
-
Regulatory Affairs Director
hace 6 días
Madrid, España MCR International A tiempo completo**CLM-2210-83** **REGULATORY AFFAIRS DIRECTOR** **MADRID** From MCR International, we are looking for a **Regulatory Affairs Director** for a well known Pharmaceutical company based in Madrid with the possibility of working remotely 50%. **Mission**: Define and implement the regulatory strategies to obtain marketing authorizations for the company's...
-
ED&CP Regional Site Strategy Lead
Encontrado en: beBee S ES - hace 4 semanas
Madrid, España Johnson & Johnson A tiempo completoPosition Summary: The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...
-
Ed&cp Regional Site Strategy Lead
hace 4 días
Madrid, España Johnson & Johnson A tiempo completo**Position Summary**: The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...
-
Director Regional Galicia
hace 4 días
Madrid, España Rebel Talent A tiempo completoNuestro cliente es una empresa multinacional de servicios integrales relacionada con las infraestructuras y presentes en la conservación, mantenimiento, rehabilitación, etc. Actualmente nos encontramos en la búsqueda de su próximo/a Director/a Regional de la zona de Galicia, área que deberá liderar y representar. Será responsable de hacer crecer...
-
Director Regional Horeca
Encontrado en: beBee S ES - hace 3 semanas
Madrid, España L4Talent - Looking For Talent A tiempo completoEstamos buscando un Director Regional para una reconocida empresa del sector Gran Consumo ResponsabilidadesLiderar y gestionar el equipo comercialDiseño y desarrollo de la estrategia comercial y de Trade MarketingNegociación de acuerdos comercialesDesarrollo de política y estrategias promocionalesControl y análisis de ventasReportingRequisitos:Mínimo...
-
Director Regional Horeca
Encontrado en: beBee S ES - hace 4 semanas
Madrid, España L4Talent - Looking For Talent A tiempo completoEstamos buscando un Director Regional para una reconocida empresa del sector Gran Consumo ResponsabilidadesLiderar y gestionar el equipo comercialDiseño y desarrollo de la estrategia comercial y de Trade MarketingNegociación de acuerdos comercialesDesarrollo de política y estrategias promocionalesControl y análisis de ventasReportingRequisitos:Mínimo...
-
Director of Strategy EMAP
Encontrado en: Talent ES C2 - hace 3 semanas
Madrid, España Experian A tiempo completoJob Description The Director of Strategy is a highly visible and influential role; pivotal to the future success of the organisation as it enters a phase of accelerated growth. The role reports to the Chief Commercial Officer – EMAP and serves as a member of the EMAP Senior Management Team. The Director of Strategy will be responsible for...
-
Regulatory Manager
hace 6 días
Madrid, España INSUD PHARMA, S.L.U. A tiempo completoOverview: **General Responsibility** The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout...
-
Regulatory Manager
hace 3 días
Madrid, España Precision For Medicine A tiempo completoPrecision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. Position Summary: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings,...
-
Regulatory Affairs Manager
hace 2 semanas
Madrid, España Adqualis A tiempo completoImportante Laboratorio Farmacéutico Chino de genéricos y biosimilares dentro de los Top 10 en su país; en pleno proceso de crecimiento y expansión en Europa precisa incorporar a un/a Regulatory Affairs Manager para su HQ Europeo en Madrid.En dependencia de la Dirección del Área se encargará principalmente de garantizar que los productos de la...
-
Ram / Regional Acces Manager
hace 3 días
Madrid, España MCR International A tiempo completo**ASP-2303-61** **RAM / REGIONAL ACCES MANAGER** **MADRID** **We are looking for our client a RAM / REGIONAL ACCES MANAGER for Madrid.** *** **Functions**: He/ she will be responsible for the execution of the market access strategy in order to secure timely and valuable access compounds in his/her area of responsibility while also assuring availability...
-
Senior Regulatory Science and Strategy Lead
Encontrado en: Talent ES C2 - hace 3 semanas
Madrid, España IQVIA A tiempo completoOverview Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions. We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in...
-
Regulatory Affairs Intern
hace 3 días
Madrid, España Kenvue A tiempo completo**Regulatory Affairs Intern**-2307004145W Description Cooperation with Commercial/Marketing teams. **Medicines Regulatory activities**: - New marketing authorization activities - Maintenance activities of existing licenses: preparations of administrative, quality regulatory packages and safety related variations for their submission to Healthcare...
-
Regulatory Affairs Professional
hace 1 semana
Madrid, España Parexel A tiempo completoMadrid, Spain **Job ID** R0000013557 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The...
-
Regulatory Affairs Professional
hace 2 días
Madrid, España Parexel A tiempo completoWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. **Key Deliverables in the role**: - Manage...
-
Director Regional Cosmetics
hace 4 días
Madrid, España Antal International A tiempo completoLaboratorio cosmético francés con más de 25 años de trayectoria, necesita incorporar en su equipo un/a Director Regional. El DR será responsable de la gestión del equipo de sell in y sell out, así como de la estrategia de ventas, la rentabilidad de cada cuenta de cliente y el respeto por parte del equipo de la aplicación de los procesos...
-
Regional Director, Iberia
Encontrado en: Talent ES C2 - hace 6 días
Madrid, España Axon A tiempo completoYour Impact The Regional Director, Iberia is responsible for managing a direct team of salespeople, supported by local employees of our wider EMEA sales engineering, customer success and technical teams that sell the Axon product line of less lethal weapons and software solutions to public safety agencies and growing Axon’s business as a whole in across...
-
Regional IT Procurement Manager
Encontrado en: Talent ES C2 - hace 6 días
Madrid, España SGS A tiempo completoJob Description As part of the SGS Global Procurement & Real Estate team, the Regional IT Procurement Manager will mainly focus in defining and implementing the IT category strategy at a regional level but also coordinate and support regions and countries to optimize their IT Spend by taking ownership of the IT procurement performance. Reporting line: ...
-
Madrid, España Novartis A tiempo completoLeads development and execution of key product portfolio, BD&L and M&A strategic initiatives for Region International (LatAm, AME, APAC), incl. commercial due diligence, forecasting and valuation, KPIs development and implementation and process improvements initiatives. Your responsibilities will include, and will not be limited to: - Drives increase in...
-
Director, Product and Bd Strategy, Sandoz
hace 1 semana
Madrid, España Sandoz A tiempo completoJob ID- 374965BR- Jul 25, 2023- Spain**Job Description**: - 2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz,...