Associate Director Regulatory Affairs - Emerging Markets - High Wycombe

High Wycombe
60,000 - 80,000
29 Nov 2018
27 Dec 2018
Regulatory Affairs
Contract Type
Mary Bolt at CK Clinical is recruiting for an Associate Director Regulatory Affairs - Emerging Markets to join a highly established research-based pharmaceutical company with a mission to change the way diseases are managed, interpreted, and prevented at their site based in High Wycombe on a permanent 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:
Your main duties will be to:
-Be responsible for strategic and tactical input into development, post-approval and Life cycle management, liaison with Regulatory Agencies (RA) and Local Operating Companies as well as input into document and process development and Clinical Trial Applications (CTA).
-Develop and ensure effective implementation of regional regulatory strategy and tactics in support of the global development and life-cycle management (LCM) plan and advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates.
-Establish and maintain positive relationships with authorities and effectively negotiate on product-specific labelling, study design, submissions content, and post-approval commitments as well as ensuring appropriate implementation of scientific advice / Regulatory Agency comments into development and LCM plan.

Further responsibilities will include:
-Providing input to and reviewing submission documents to ensure that they are fit for purpose and support labelling statements as appropriate as well as ensuring protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling.
-Ensuring appropriate involvement and liaison with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings and planning and developing briefing documents for meetings with RA, including determining content and review of documents.
-Providing input for developing and updating the Target EU SmPC based on your knowledge of the implications of regulatory strategy for labelling

Your Background:
The ideal candidate for this role will have:
-Educated to degree level or above in life science or a related field with extensive experience within Regulatory Affairs up to a Senior level.
-Experience of working with MAA registrations across the Emerging Markets and particularly with oncology products.
-Experience of working in project teams and/or a matrix organization, with Negotiating and conflict handling skills as well as excellent people management and interpersonal skills

The Benefits:
A very competitive package is on offer including a car allowance, bonus and other benefits.

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 CL44049 in all correspondence.

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