Lead Regulatory Scientist
I am working with a top pharmaceutical company in Hertfordshire who is looking for a Regulatory Partner to join them in a 12-month contract.
This role will be joining the UK Regulatory Affairs team, part of the Medical Licence to Operate Group alongside Drug Safety, Quality and Medical Information.
In this Senior regulatory role (known internally as LTO Partner: Regulatory) you will provide strategic and technical advice within the department and across the business and be responsible for regulatory management of marketed medicines in the UK and innovative development products that will be submitted post EU exit. You will mentor and coach the Regulatory Affairs team to upscale their strategic and technical knowledge.
In this role you will proactively:
- Support the department in preparations for Brexit.
- Represent UK Regulatory Affairs (DRA) both externally, internally at EU/HQ level, and in cross-functional teams to support the business.
- Lead in interactions with national regulatory agencies on policy, scientific advice and product issues.
- Give strategic and relevant regulatory input to support development and lifecycle management.
- Know the brand strategies, ensuring timely communication of regulatory activities and timelines to support brand planning.
- Build contacts and understanding across the business, identifying business opportunities for Regulatory Affairs.
- Demonstrate leadership and ability to think beyond immediate responsibilities and apply knowledge to new situations.
- Seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas.
- Assess content of proposed national submissions, proposing solutions to correct deficiencies and ensuring high quality regulatory submissions are made and implemented in a timely manner in collaboration with colleagues to maintain compliance.
- Ensure questions and commitments from our national regulatory authorities are proactively managed.
- Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools, templates.
- Be able to coach less experienced colleagues in their work.
This role requires demonstrated regulatory judgment and understanding of the changing regulatory environment. Key skills and experience are:
- University degree or equivalent, preferably in a scientific discipline. Further education or training in Regulatory Affairs desirable.
- Successful track record in Regulatory Affairs, including stakeholder management and experience of UK or EU management of Marketing Authorisations and CTAs. Experience in other aligned areas e.g. drug safety, clinical trials, discovery or development research desirable.
- Planning and project management of large, complex activities.
- Proven successful interactions with health authorities, both through face-to-face meetings as well as through MAA procedures.
- Ability to communicate across all levels, teamwork, IT skills.
- Excellent attention to detail, accuracy.
If you are interested in finding out more about this role then please send your CV to Sabrina Deo at email@example.com