Associate Director, Regulatory Liaison, EMEA in Buckinghamshire
Brandon Whates is recruiting for an Associate Director, Regulatory Liaison, EMEA to join a well-established and highly regarded pharmaceutical company based in Buckinghamshire on a permanent basis.
The successful applicant will be working within the oncology team. They will be responsible for providing strategic oversight in relation to drug development, post-approval and lifecycle management for their range of oncology products.
Working closely with Project Managers, Therapeutic Area Leaders and Study Teams, they will provide advice on regulatory guidelines in EMEA regions and promote the implementation of regulatory strategies that will positively affect lifecycle maintenance and global development. This is a great opportunity for someone with strong regulatory experience in drug development and commercialisation, and a comprehensive knowledge of regulatory procedures within EMEA regions.
- Be responsible for filing products following EU centralised procedures and playing a core operational role within the oncology team.
- Provide advice to study teams regarding specific regulatory issues that may affect a project.
- Develop and implement effective regulatory strategies in support of lifecycle maintenance and global development.
- Maintain strong relationships and effectively negotiate with Regulatory Agencies on product-specific labelling, study design, submission content and post-approval commitments.
- Provide regulatory support for market authorisation applications.
- Act as a primary contact with EMEA and work through LOC and/or CRO for National Regulatory Agencies contacts.
- Determine 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).
- Provide line management, mentoring and guidance to Regulatory Professionals.
- Determine resource requirements for assigned projects and anticipate needs.
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.
- Strong knowledge of regulatory requirements within EMEA regions.
- 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.
A very competitive package is on offer including a car allowance, bonus and other benefits.
For more information or to apply for this position, please contact Brandon Whates on 01438 768715 or email email@example.com. 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 44613 in all correspondence.