CK Group are working with a very well backed biotechnology company, with a strong pipeline who are looking for an Associate Director, Regulatory Affairs, for a six-month contract. The role will be in support of their expanding Oncology portfolio, extensive Oncology experience is an absolute must, radiopharmaceuticals experience would be highly advantageous. Ideally the role will be hybrid, with three days a week in the Cambridge office, though a fully remote role could be considered for an ideal candidate.
RESPONSIBILITIES:
As Associate Director, Regulatory Affairs you will be responsible for oversight of the operational execution of Regulatory submissions for their assigned programs or projects, working closely with cross-functional colleagues.
Key duties will include:
Responsibility for the development and execution of regulatory strategy for assigned programs or projects, including development and maintenance of the Regulatory Plan.
Oversight of the preparation and execution of global regulatory submissions for assigned programs or projects, in collaboration with the Regulatory Lead.
Responsibility for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file.
Manage the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned programs or projects, which may include some strategic submissions such as INDs, CTAs, NDAs, MAAs, pediatric plans, orphan drug designations and/or expedited program submissions, etc.
Monitoring the regulatory landscape to anticipate and adapt to changes that may impact assigned programs or projects.
Development and maintenance of internal cross-functional relationships to support the development and execution of regulatory strategy assigned programs or projects.
QUALIFICATIONS:
As Associate Director, Regulatory Affairs you will require:
Bachelor’s degree in a scientific field or post-graduate degree preferred.
Extensive industry-based experience in Regulatory Affairs in support of Oncology products, ideally with a radiopharmaceuticals background also.
Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.
Experience and knowledge in preparation of INDs, CTAs, NDAs, MAAs or regional equivalents is required.
An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
Ability to proactively identify risks and develop risk mitigation strategies.
BENEFITS:
Excellent day rate.
APPLY:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.
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