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Job Details

Associate Director Regulatory Labelling - Hertfordshire

Company: CK Clinical
Location: Hertfordshire
Reference: CL42143
Closing Date: 14 Jun 18
Type: Permanent
Salary (£): Negotiable

Job Summary:

Mary Bolt is recruiting for an Associate Director Regulatory Labelling to join a global pharmaceutical company committed to contributing to better healthcare at their site...


Mary Bolt is recruiting for an Associate Director Regulatory Labelling to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a permanent basis.

The main purpose of the role will be to:
-Provide leadership within the Global Labelling function in the UK, promoting and creating a professional environment and partnering with key stakeholders to facilitate and lead cross functional teams in the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products and Country Product Information (CPI) and CPI components for assigned products.
-Assist in the development of global regulatory labelling strategy and update strategy based upon regulatory changes as well as anticipating regulatory labelling obstacles and emerging issues throughout the product lifecycle and developing solutions with other members of regulatory and related teams.
-Represent the Global Labelling function on project teams and regulatory sub teams as appropriate, and coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects, including QC, proofing, copy editing and formatting of documents, and coordinating review and approval of final submission.

Further responsibilities will include:
-Utilisation of regulatory expertise to review, develop and deliver core/local labelling documents such as the CPI and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
-Maintaining labelling history documents and assisting in responding to labelling-related queries from various functional areas as well as maintaining expertise regarding key labelling requirements worldwide and staying current with labelling guidelines and regulations on a global basis.
Communicating, planning, prioritising and delivering labelling documents according to company targets and submission requirements, liaising with stakeholders using the most effective means of communication and presenting information in an optimal format and level of information for that audience.
-Supervising direct reports and develop and mentor direct reports on both operational and strategic aspects of labelling.

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 extensive experience in Regulatory within the pharmaceutical industry and solid experience in labelling including knowledge of global regulations, guidance documents and ICH guidelines regarding labelling requirements and demonstrated ability to apply regulatory guidelines to product labelling.
-Demonstrate a solid working knowledge of drug development processes as well as US and EU labelling and experience of European regulatory procedures (Centralised, MRP and DCP).
-Proven interpersonal skills including negotiating, communicating, coaching & explaining as well as strong project management, people management, problem solving and strategic thinking 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 CL42143 in all correspondence.

Apply for this job: Associate Director Regulatory Labelling - Hertfordshire

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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