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Associate Director, Regulatory Affairs CMC

Aalsmeer, Netherlands

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Job Description

We are looking for experienced regulatory professionals to join our global team 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 serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.

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

  • Participate on other sub-teams (e.g., Study Management, Clinical). Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plan.

  • Oversee and guide the preparation, compilation, and timely filling 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).

  • Maintain submission content and make 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 biologics but ideally also 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 is 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Blijf op de hoogte van de laatste farma vacatures


Blijf op de hoogte van de laatste farma vacatures