Director, Global Regulatory Affairs - Europe

Das ist der Job

The role can be remotely based across Germany.

Das brauchst du

Director, Global Regulatory Affairs for well-established, global pharmaceutical organisation seeking an EU-focused leader Full-time, permanent Germany Die folgenden Informationen geben Ihnen einen Überblick über die Fähigkeiten, Qualitäten und Qualifikationen, die für diese Stelle erforderlich sind. - remotely based Join a global biopharmaceutical organization dedicated to advancing innovative therapies for patients around the world.

Darum lohnt es sich

Provide regulatory leadership across cross-functional development and governance teams, influencing portfolio decisions and ensuring European considerations are integrated into global development strategies and business priorities.

Exceptional strategic, communication, leadership, and influencing skills, with the ability to lead cross-functional teams in a global matrix environment, influence without direct authority, negotiate effectively with regulators, and develop regulatory talent. xayajpt Contact If you're interested in learning more, apply to this job post.

As the Director of Global Regulatory Affairs for EU, you will lead the regulatory strategy development to support clinical development, market authorisation applications, lifecycle management activities, regulatory governance, and regulatory compliance.

This is a highly visible leadership role offering the opportunity to shape global regulatory strategy as they partner with global and local regulatory personnel.

Responsibilities Develop and execute strategic European regulatory strategies across clinical development, registration, commercialization, and lifecycle management, identifying risks, opportunities, and appropriate mitigation strategies.

Lead regulatory submissions and activities including MAAs, Scientific Advice, PIPs, Orphan Drug Designations, variations, renewals, labeling updates, new indications, manufacturing changes, and safety-related submissions.

Serve as the primary regulatory representative with the EMA and European national competent authorities, leading preparation for regulatory meetings, Scientific Advice procedures, oral explanations, inspections, and other health authority interactions.

Lead regulatory intelligence and compliance activities while mentoring regulatory professionals, supporting capability development, and contributing to process improvements and operational excellence across the European Regulatory Affairs function.

Requirements Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline required; advanced degree such as an MS, PharmD, PhD, or MD preferred. 10+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, with significant experience leading European drug development and marketing activities.

Proven experience developing and executing complex regulatory strategies for innovative medicines, including global development programs and both development-stage and marketed products.

Expert knowledge of European pharmaceutical regulations, regulatory pathways, ICH guidelines, and EU pharmaceutical legislation, with demonstrated experience interacting directly with European health authorities. To contact Amit directly, reach out to him at