Reference Number: JO-2203-489459
Regulatory Affairs Consultant
Rate: Negotiable
Job Type: Contract
Location: Central London / West End

Regulatory Affairs Consultant
Initial 6 month contract
Fully remote
Offering up to 60.00 Per Hour via an Umbrella solution
ASAP start

CPL Life Sciences have joined forces with a leading biopharmaceutical organisation who is urgently seeking an experienced Regulatory Consultant on a 6 month contract to support a key phase 3 trial for a major oncology asset.

Job Requirements include;
Co-ordinate regulatory submissions for assigned projects and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Primarily, prepare and co-ordinate regulatory documentation to support development, focusing on Clinical Trial Applications/amendments, acting where required as the single regulatory lead for a study.
Potentially, for marketed products, prepare and/or co-ordinate the submission of clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the Marketing Authorisation Holder via the European Centralised procedure.
Interacts with the Regional and Global Regulatory Leads, and cross-function teams to ensure optimal execution of the agreed regulatory strategy

Candidate Requirements include;
Eligibility to live and work in the United Kingdom
Life Science degree and demonstrated relevant regulatory affairs experience
Good knowledge of regulatory requirements for the EU centralised procedure
Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials

If this is an opportunity of interest to you please forward your up to date to Sophie.Malyon@cpl.com.

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