Senior Regulatory Affairs Project Manager in High Wycombe

Location
High Wycombe
Salary
Negotiable
Posted
03 Jan 2019
Closes
31 Jan 2019
Ref
KA44297
Discipline
Regulatory Affairs
Contract Type
Contract
Lucy Stendall 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.

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.

Role Purpose:
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.

Accountabilities:
• Provide Regulatory support for a portfolio of promoted and non-promoted products.
• Prepares and submits regulatory documentation with support from RSMO as required.
• Monitors deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA.
• Responsible for the content of the local labelling documents released to prescribers and
patients.
• Prepares and distributes local labelling documents within stipulated timelines following
receipt of relevant approvals from RRR.
• Prepares for and manages local procedures following the EMEA Regulatory Affairs
strategic plan, assuring timely execution and compliance.
• Partner with allocated CVT to provide RA expertise and support Implements of Risk.
• Management Plans and when required co-ordinates cross functional team to
implement/update Risk Management Educational Material.
• Complete above activities to ensure compliance with all regulatory requirements.
• Develops and maintain in depth knowledge of regulations/legislation.
• Supports EMEA with collection of RA competitive intelligence as required.
Internal contacts:
• Support other departments based on their needs (e.g. Supply Chain, Quality, Medical,
and Commercial) by providing documentation and information in response to requests.
External contacts:
• Contact local Health Authorities to resolve general queries (some product specific)
when these cannot be addressed internally ensuring a positive interaction in any
communication.
• Support and contribute to GRA-EMEA initiatives as requested by Head of RA.
• Contribute to initiatives around lessons learnt and change management to ensure
efficiency gains.
• Actively contribute to increasing the regulatory expertise of the team by mentoring of
junior regulatory colleagues.
Key Line Management Activities:
• Conduct formal performance and career conversations with all direct reports according
to the framework set.

Education, Qualifications, Skills & Experience:
To be considered for the role you should have the following skills, knowledge and experience:
• 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.
• Decision Making Autonomy.
• 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.

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 KA44297 in all correspondence.

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