Associate Director Regulatory Affairs - EMEA - 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 filing products following EU centralised procedures and playing a core operational role within the oncology team.
-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.
-Act as a primary contact with EMEA and work through LOC and/or CRO for National Regulatory Agencies contacts.

Further responsibilities will include:
-Determining timing and strategy for Regulatory Agency meetings and scientific advice as well as preparing the team, managing, conducting and facilitating contacts/meetings with Regulatory Agencies (RA's).
-Providing Regulatory support throughout the registration process and Life-cycle management of Marketing Authorisation applications and manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate).
-Provide line management, mentoring and guidance to Regulatory Professionals.
Your Background:
The ideal candidate for this role will have:
-Education to degree level or above in life science or a related field with extensive experience within Regulatory Affairs up to a Senior level.
-Experience with EU regulatory procedures (CP, MRP, national), within project teams and/or a matrix organization and particularly experience with Oncology products.
-Excellent skills in Negotiating, conflict handling and people management as well as leading regulatory projects.

The Benefits:
A very competitive package is on offer including a car allowance, bonus and other benefits.
Alternatively, please click on the link below to apply online now. 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 CL44048 in all correspondence.

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