My client is a large biotech company who are looking for a Regulatory Affairs Senior Manager to join their UK affiliate team.
You will be representing the UK and Ireland and will be responsible for advising the international and global colleagues on considerations in developing strategy and ensuring the country needs are well defined and implemented in collaboration with relevant stakeholders.
You will be playing a crucial role within the team ensuring all licences are attained to support clinical trials for pre and post marketed products. This is an exciting role offering lots of variety as well as progression and exposure for the right person.
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
- Lead development of local regulatory documents and meetings in accordance with GRT strategy
- Provide regulatory direction on regulatory mechanisms to optimize local product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
- Participate in the development and execution of regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
- Partner with brand teams and review promotion and non-promotion materials and activities to ensure commercial compliance with licence
- Degree educated in a scientific discipline
- Extensive experience in GB and European regulatory environment
- Proven track record of developing and executing regulatory strategy
- In-depth understanding of the drug life cycle and development process from a regulatory perspective
- In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Ability to lead teams and work collaboratively in a dynamic environment
- Proactive approach to problem solving
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate regulatory agency expectations
- Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
My client offers remote working, with the occasional travel to their Cambridge office 3-4 times a month, excellent working conditions, with the support and opportunities to progress further into your career, along with a comprehensive benefits package.
If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar or Kayleigh Cumming on +441293 364095, or apply with your CV.
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