Associate Director - EU Regulatory lead (4517)

CK Group are recruiting for a EU regulatory lead to join a global pharmaceutical company on a contract basis for 6 months, with possibility to extend for a further 6 months. This contract will fall within IR 35, and so working options are available either PAYE, via CK, or Umbrella company.

Salary: Daily rate available up to £750 per day (umbrella company)

EU Regulatory Lead: The role/seniority is the one of an Associate Director, and the contractor will need to be flexible and support various activities depending on the workload within the team. However, the activities may vary from early development products, where they will be required to lead preparations of Health Authority meetings (national scientific advice), Orphan designation submissions, paediatric plan preparations, or marketed products (pediatric plans, variation submissions, renewals, etc)

• Collaborates to define, develop and lead regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
• Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Leads the Regional Working Team and represents the region as needed on global and project teams
• Provides regional regulatory expertise for assigned development and/or life cycle management project(s) within the therapeutic area of responsibility
• Manages and oversees interactions with EMA and national health authorities and HTAs (jointly with value and access team in context of parallel consultation) in the Europe Region for products within their responsibility.

Your Background:

• BSc. advanced scientific related degree preferred;
• Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region (as relevant to role) with global involvement also preferred
• Able to train/develop junior colleagues in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
• Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategiesApply: For more information or to apply for this EU Regulatory lead please contact Steve on 01246 457733 or email slord@ckgroup.co.uk. 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 5working 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 52607 in all correspondence.