GRA Device Lead (Director) - all genders - Inklusiver Job

Sanofi-Aventis Deutschland GmbH; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global healthcare company is seeking a Regulatory Affairs Lead for Specialty Care Combination Products in Frankfurt. The role focuses on overseeing regulatory activities for innovative medical devices and combination products, ensuring compliance and driving discussions with regulatory authorities. Candidates should have experience in regulatory affairs and strong communication skills. This position offers ample opportunities for career growth and development.

Qualifikationen

• Experience in regulatory affairs, particularly with combination products and medical devices.
• Ability to work in a matrix environment and independently on projects.
• Strong communication skills to engage with stakeholders and regulatory authorities.

Aufgaben

• Oversee key regulatory activities for specialty care combination products.
• Develop and maintain project regulatory strategy documents.
• Drive discussions with regulatory authorities and contribute to industry standards.

Jobbeschreibung

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The GRA Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.

Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care Combination Products, who in turn reports to the Head of GRA Device. The candidate will work within a matrix environment, operating as a strong independent contributor on assigned projects. The role will represent the GRA Device perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain device aspects of project regulatory strategy documents.

The incumbent will provide strategic and tactical support on Sanofi's combination product portfolio and will also have the opportunity to work on other innovative projects. The incumbent will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need "new" thinking and approaches from a regulatory perspective. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards.

This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of Sanofi's exciting development pipeline.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?