Associate Director, Regulatory Affairs CMC

Arbeitsbeschreibung

We are looking for an experience Regulatory professionals to join our global team here in the Netherlands.

In this role, you will be responsible for acting as one of the EU Regulatory leads for Kite's existing commercial and/or clinical programs. Your duties will include defining the regulatory strategy, plans, and objectives for assigned products or projects. Additionally, you will contribute to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.

You will take the lead on CMC submissions and collaborate with headquarters colleagues to shape dossier content for global rollout and life cycle management in EU-aligned regions. Serving as a Kite contact for regulatory authorities, you will oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising colleagues to ensure thorough and compliant completion of these activities.

Furthermore, you will play a leadership role in ad hoc or special projects aimed at continuously improving or advancing Regulatory Affairs capabilities.

In your new role, you will:

• Represent Regulatory Affairs and may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.

• Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

• May participate on other Sub-teams (e.g., Study Management, Clinical,) Proactively identify regulatory or related risks/issues and develops mitigation and/or contingency plan.

• Oversee and guide the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, investigational medicinal product dossiers (IMPDs), variations to the commercial marketing authorization and substantial modifications to the clinical trial (CMC)

• Maintains submission content and updates in the appropriate electronic systems

Your profile

We are all different, yet we all use our unique contributions to serve patients. We are looking for you if you have:

• Advanced degree in life sciences and 5+ years’ relevant experience in CMC related regulatory affairs or alternatively a BA/BS or equivalent with 6-8+ years’ relevant experience in CMC related regulatory affairs.

• Strong life sciences background, ideally in cell & gene therapy

Knowledge & Other Requirements

• In-depth knowledge of current global and regional trends in minimally biologics but ideally cell and gene therapy regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.

• In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements. Evidence of prior successes in conducting HA interactions a plus.

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives to support a team-oriented, highly matrixed environment.

• Demonstrated ability to learn quickly while being flexible and adaptable to change, and to move between projects easily and provide support/expertise where needed.

• Demonstrates strong attention-to-detail and good organizational skills. Ability to communicate in a clear and concise manner verbally and in writing.

• Excellent knowledge of Microsoft Office tools and the Veeva platform quality/regulatory/compliance systems expected.