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Job Details

Senior Regulatory Project Manager - High Wycombe

Company: CK Clinical
Location: High Wycombe
Reference: CL41874
Closing Date: 11 Jun 18
Type: Permanent
Salary (£): 40,000 - 60,000

Job Summary:

Mary Bolt is recruiting for a Senior Regulatory Project Manager to join a highly established research-based pharmaceutical company at their site based in High Wycombe...


Mary Bolt is recruiting for a Senior Regulatory Project Manager to join a highly established research-based pharmaceutical company at their site based in High Wycombe on a permanent basis.

The main purpose of the role will be to:
-Provide Regulatory support for a portfolio of promoted and non-promoted products and manage processes to ensure compliance with regulatory requirements and an inspection ready culture.
-Prepare and submit regulatory documentation with support as required and monitor deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA.
-Be responsible for the content of the local labelling documents released to prescribers and patients and prepare and distribute local labelling documents within stipulated timelines following receipt of relevant approvals.

Further responsibilities will include:
-Preparing for and managing local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance as well as partnering to provide RA expertise and supporting Implements of Risk Management Plans and when required co-ordinating the cross functional team to implement/update Risk Management Educational Material.
-Developing and maintaining in depth knowledge of regulations/legislation and supporting EMEA with collection of RA competitive intelligence as required.
-Contacting local Health Authorities to resolve general queries (some product specific) when these cannot be addressed internally ensuring a positive interaction in any communication.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science or a related field with Regulatory Affairs experience at an operational level.
-Direct experience and strong knowledge of general regulatory requirements and guidelines.
-Strong data gathering and analytical skills as well as strong persuading/ influencing, and negotiating skills.

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 CL41874 in all correspondence.

Apply for this job: Senior Regulatory Project Manager - High Wycombe

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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