Mary Bolt at CK Clinical is recruiting for a Senior Regulatory Affairs Manager, CMC, LAM Liaison to join a leading, privately owned, global pharma with significant presence in several therapeutic areas at their site based in Cambridge on a permanent basis.
Our client our global leaders in their field with significant presence in multiple therapeutic areas, producing medicines that provide cost-effective solutions to patients needs
The role is based at our client's site in Cambridge, a town famous for it's history, university and architecture. There is also the added benefit of being accessible to London and Stanstead and Luton airports.
The main purpose of the role will be to:
-Proactively manage assigned Regulatory CMC and compliance activities, provide CMC strategy, advice and information to RA Strategic Team leaders, internal departments, Associated Companies and Licensees and provide CMC input on development project strategies and support to ongoing development projects.
-Take a high level of personal responsibility and accountability for managing and delivering complex Regulatory projects, for problem solving, and business critical decisions and project manage and lead tasks, which may have a high degree of impact to the business.
- Mentor, provide guidance and support to other team members including advising junior staff on data requirements for their activities and ensuring appropriate training and development of staff as well as evaluating the performance of regulatory staff on an ongoing basis and taking appropriate steps to address any issues.
Further responsibilities will include:
-Preparing state of the art, compliant CMC documentation to support clinical trial applications, marketing authorisation applications and product life cycle maintenance via renewals and variations in accordance with any applicable regulatory guidelines and good regulatory practice and where appropriate, using the electronic document and data management system.
-Taking a high degree of personal responsibility for representing the Company both internally and externally and responding directly to questions from associate companies regarding CMC registered information.
-Evaluating the impact of new regulations on the business and undertaking appropriate action as well as developing and documenting new working practices and ensuring that department procedures are followed.
To succeed in this role, you will come from a background in:
-Educated to degree level or above in life science or a related field with extensive experience within Regulatory Affairs and an in-depth knowledge of technical and scientific information, legislation and relevant Regulatory Guidelines and can assess their impact on the business.
-Have a comprehensive breadth of technical regulatory experience including CP/DCP/MRP National procedures and preparation of IMPD/IND/M2.3/M3.
-Demonstrated success in delivering large complex projects, exceptional written and oral communication skills and IT literate, particularly in relation to using databases and document management systems.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL42710 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Mary Bolt
- Phone: 01438 743047
- Reference: CL42710
- Posted: 8th August 2018
- Expires: 5th September 2018