CMC Regulatory Affairs, Manager

CMC Regulatory Affairs, Manager

Gilead

Amsterdam, Netherlands

Job Description

As CMC Regulatory Affairs, Manager you will be based in Hoofddorp, the Netherlands and you will be part of the Kite CMC Regulatory Affairs team. In this role you will lead the delivery of CMC Quality components for clinical trial applications, marketing applications and post-authorisation submissions in Europe and Rest of World (RoW) countries.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

You will be reporting to the Senior Manager CMC, Regulatory Affairs (who is based in the UK).

Your Responsibilities

  • Prepare the Quality sections of IMPDs, marketing applications and CMC variations for submission in Europe and RoW. Ensure that dossiers meet ICH and local regulatory requirements, and are aligned with the overall regulatory business strategy.
  • Work with Kite Technical Operations, Manufacturing and Quality colleagues to develop regulatory strategy for CMC content and lifecycle maintenance, including provision of advice on regulatory requirements for post-authorisation change management.
  • Work with Technical Operations, Manufacturing and Quality colleagues to co-ordinate the preparation of responses to CMC questions from regulatory agencies.
  • Assess CMC-related changes and rapidly adapt strategy to unanticipated changes as needed.
  • Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans.
  • Liaise with International Regulatory, including local affiliates, CMC Project Management and Regulatory Operations to define/clarify CMC submission requirements, and execute the timely filing of regulatory submissions.
  • Maintain an up to date awareness of CMC regulatory requirements on cell and gene therapy for applicable territories and communicate key intelligence to the organisation in a timely manner.

Your Profile

  • Bachelor’s degree with more than 5 years of relevant regulatory drug development and life-cycle management experience required, including prior experience in preparation of CMC regulatory submissions for ATMPs and/or biological medicinal products.
  • Must have an in-depth knowledge of CMC regulatory requirements for ATMPs and/or biological medicinal products, and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
  • A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
  • Excellent communication skills, both written and verbal.
  • Excellent influencing and negotiation skills.
  • Must have a “can do” attitude and be “hands on” as and when required.
  • Organisational skills: detail oriented and can deal with frequent changes in product activity.
  • Ability to adapt in a constantly evolving environment.
  • Self-motivated with a strong sense of ownership in areas of responsibility.
  • High degree of professionalism, ethics and integrity.
  • Comfortable in a collaborative, fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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