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Job Details

Contractor Regulatory Affairs, Oncology - Hertfordshire

Company: CK Clinical
Location: Hertfordshire
Reference: CL42395
Closing Date: 16 Jul 18
Type: Contract
Salary (£): Negotiable

Job Summary:

Mary Bolt is recruiting for a Contractor Regulatory Affairs - Oncology to join a global pharmaceutical company committed to contributing to better healthcare at their site...


Mary Bolt is recruiting for a Contractor Regulatory Affairs - Oncology to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a 12 month contract basis.

The main purpose of the role will be to:
-Provide regulatory support to project teams for allocated projects including CTA, variation and PIP submissions and contribute to the planning, execution, and assessment of product life cycle management activities and strategies.
-Contribute to, and implement, strategy for interactions and negotiations with health authorities and provide strategic input into product lifecycle plans and maintain licences for marketed products.
-Prepare CTAs, MAAs, CTA amendments, Variations, Scientific Advice briefing documents, PIP modification documents etc.) for assigned projects/products in compliance with the applicable regulatory requirements.

Further responsibilities will include:
-Acting as the day to day contact point with regulatory authorities for communications relating to assigned projects/products and interacting with external stakeholders regarding regulatory issues.
-Managing and co-ordinating requests for scientific advice with regulatory agencies and the preparation of briefing packages.
-Ensuring the quality and compliance of regulatory submissions for all assigned projects/products, being responsible for the mentoring of other staff as appropriate and assisting with the creation and review of Standard Operating Procedures (SOPs).

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 signifcant experience of working within Regulatory Affairs.
-Familiarity with EU clinical trial regulations and procedures, experience of liaising with regulatory authorities (both in writing and verbally) and experience of life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions and negotiating labelling with regulatory authorities.
-Excellent written and verbal communication skills, strong problem solving skills and eye for detail, must be able to operate in a complex environment and adapt well to changes.

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 CL42395 in all correspondence.

Apply for this job: Contractor Regulatory Affairs, Oncology - 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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