Sr Manager CMC Regulatory Affairs EU

Job Description

As Associate Director, CMC Regulatory Affairs EU,you will be based in either Cambridge, UK, or Hoofddorp, the Netherlands. As part of Kite’s global CMC Regulatory Affairs team, you will lead the delivery of CMC/Quality components for regulatory submissions related to clinical trials, marketing applications and post-authorisation lifecycle management in the European Union, Great Britain and other regions as required.

Kite, A Gilead Company

At Kite, we are at the forefront of engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionising individually tailored treatments. That means a fast moving and constantly changing environment where we make discoveries every day—discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit a highly motivated and talented individual to join us and be part of our exciting journey in the development of innovative immunotherapies and their translation to the treatment of patients with cancer.

You will be reporting to the Director, CMC Regulatory Affairs EU, who is based in the Cambridge, UK, office.

Responsibilities (include but are not limited to):

• Lead the delivery of CMC/Quality components for clinical study, marketing application and post-authorisation submissions in Europe and Great Britain, and contribute to the strategy, content and review of all major and/or critical CMC submissions for which responsibility is assigned.
• Ensure that CMC dossiers meet ICH and local regulatory requirements, and are aligned with the overall regulatory business strategy.
• Work with Kite’s Technical Operations organisation and governing committees to develop regulatory strategy for CMC content and lifecycle maintenance, including provision of advice on regulatory requirements for pre- and post-authorisation change management.
• Work with Kite’s Technical Operations organisation and governing committees 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 action including anticipation of regulators’ responses through scenario planning and development of contingency plans.
• Liaise with Gilead ACE Regulatory Affairs (including local affiliates), Kite CMC Project Management, and Gilead Regulatory Operations to define/clarify CMC submission plans and 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.

Requirements:

• PhD with 5+ years’ experience in CMC Regulatory Affairs, or MSc with 8+ years’ experience in CMC Regulatory Affairs, including prior experience in preparation of CMC regulatory submissions for clinical/commercial 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.
• Experience with regulatory submission software.
• 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.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.

Would you like to know more before you apply? Please visit us atwww.kiteamsterdamcareers.com

Only candidates in possession of a valid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.