Associate Director, Regulatory Affairs, EU & RoW

Das ist der Job

Responsibilities Provide regulatory strategic insight and procedural expertise as the principal regional liaison.

Darum lohnt es sich

Lead cross‑functional teams, aligning on strategy, risk assessment, and critical decisions. Research and analyze applicable regulatory information and provide intelligence to the team. Additional Skills / Experience Embodiment of the company’s core values: courage, community spirit, patient focus, and teamwork.

Ability to travel 10% domestically and internationally. #J-18808-Ljbffr Position Summary Associate Director, Regulatory Affairs (EU/RoW) provides strategic and technical regulatory leadership for the development, registration, commercialization, and lifecycle management of novel therapies in the orphan and rare disease space.

As the principal regulatory representative for programs across the European Union and Rest of World, this role develops and executes regional regulatory strategies and leads regulatory interactions with authorities and stakeholders. Establish regulatory objectives, strategic priorities, and regional plans for assigned programs.

Ensure regulatory strategies support program milestones, proactively mitigating regulatory risks. Assess regulatory risks, evaluate options, and make recommendations that influence timelines and objectives. Influence senior leaders and stakeholders to resolve complex development and registration challenges.

Serve as the primary regional regulatory representative and decision‑maker for assigned programs. Develop and maintain regulatory and technical sections of pre‑approval, MAA, and post‑approval submissions. Oversee preparation, review, and submission of clinical trial, pre/post‑authorization documents, and responses to regulatory agencies.

Perform other activities assigned by the Executive Director of Regulatory Affairs. Education / Experience Requirements Bachelor’s degree in a biological science (advanced degree preferred); equivalent education‑experience combination acceptable.

At least 8 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry or a government health agency, with demonstrated leadership of complex programs and strategic interactions with major health authorities.

Track record of successful approvals from a major regulatory agency required; prior regulatory agency liaison experience essential. Solid expertise in the drug development process. Ability to apply scientific principles to assess regulatory issues and draw valid conclusions.

Experience interpreting and applying ICH and EU guidelines relevant to product development and submission of pre/post‑authorization applications. Extensive track record in drafting and reviewing regulatory submissions (CTA, MAAs, variations). Strong professional experience in a similar regulatory role within the pharmaceutical industry.

Organized, multitasking, prioritizing, and managing shifting responsibilities in a dynamic, cross‑functional environment. Excellent collaboration, attention to detail, and ability to handle complexity. Strong interpersonal and organizational skills; excellent verbal and written communication.