Senior Regulatory Affairs Project Manager in High Wycombe

High Wycombe
26 Nov 2018
24 Dec 2018
Regulatory Affairs
Contract Type
Alex Tosney at CK Group is recruiting for a Senior Regulatory Affairs Project Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a 6 month contract basis.

The Company:
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.

The Location:
Working at their Headquarters in High Wycombe, the site is easily commutable. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can assess the site via the M40.

The Role:
Management of processes to ensure compliance with regulatory requirements and an
inspection ready culture including cross portfolio technical and administrative activities as required and Key therapy area regulatory support, including CVT attendance as appropriate.

Key duties include:
· Preparing and submitting regulatory documentation with support from RSMO as required.
· Monitoring deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA.
· Responsibility for the content of the local labelling documents released to prescribers and patients.
· Preparing and distributing local labelling documents within stipulated timelines following
receipt of relevant approvals from RRR.
· Preparing for and managing local procedures following the EMEA Regulatory Affairs
strategic plan, assuring timely execution and compliance.
· Partnering with allocated CVT to provide RA expertise and support Implements of Risk.

Your Background:
To be considered for the role you should have the following skills, knowledge and experience:
· Regulatory Affairs experience at operational level.
· Direct experience and strong knowledge of general regulatory requirements and guidelines.
· Strong data gathering and analytical skills are essential.
· Strong persuading/ influencing, negotiating skills are required.
· University Degree in Pharmacy, Biology, Chemistry or related Life Science.
· Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists.
· Member of The Organisation for Professionals in Regulatory Affairs.

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 KA44013 in all correspondence.

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