Our client is a prominent patient driven global biotech organisation who are looking for an experienced Regulatory Affairs professional to work on an initial 12-month contract. You will utilise your Regulatory expertise to provide support for oncology product development and implementation of regional regulatory strategies in clinical trials.
Within this role you will:
- Deliver guidance for regional regulatory strategy and support of labelling through use of strategy and management of agency collaborations
- Utilise your expertise to ensure maintenance of licenses required to support clinical trials are maintained
- Work within an innovative Global Regulatory Team, supporting and leading timely regulatory compliance for approvals
- Take responsibility for and manage regional regulatory leads and support staff
- Provide management for Regulatory employees
- Administration of core Regulatory activities
You will bring to the role:
- Strong familiarity providing strategic input from an EU perspective for clinical trials,
- Demonstrated knowledge of Regulatory principles, alongside experience with orphan drug applications, preparations for PIP’s particularly in early phase and registration strategies
- Thorough knowledge Comprehensive knowledge of full lifecycle drug management activities in the Oncology or Diabetes therapy area or with knowledge of the differences in Regulation regarding oncology
- Experience leading Health Authority interactions with EMA alongside experience acting as a Regulatory Lead for European Scientific Advice meetings
- Wholesome understanding of regulatory procedures in region EU for MAs, CTAs, post approval changes
In return you will receive:
- A role in a leading biotech company
- The ability to work in an energetic, motivated team
- A competitive salary
- Identification and reward for outstanding accomplishments
- The ability to develop within a supportive and development orientated organisation
If you have the skills and experience for this opportunity and the ambition to take on this position, please call Alouette for further details or email your CV today. Contact Alouette at +44 1273 059 765 or email@example.com.
Alouette is a Search Consultant at Haybury Search covering Europe, UK, North America and Asia.