- Develop and deliver regulatory strategy for self-care devices/pharmaceuticals
- London based role - flexible working arrangements
- Competitive salary, within a growing organisation
As Senior Regulatory Executive, you will support the development and delivery of strategy as a specialist across Medical Device, OTC or Pharmaceutical products within a self-regulatory body. Your expertise in the regulatory arena will position you as a partner to initiate change with relevant bodies.
- Provide daily regulatory support to members, working with colleagues on the correct response to regulatory and scientific issues
- Specialise in key product areas to become key point of contact for member companies in your chosen arena
- Monitor changes in the market and potential issues, applying relevant solutions through work programs
- Advise on New Product Development initiatives, including reclassification, product classification, compliance to regulations, borderline issues
- Manage working groups, sub groups and their relevant programs, advocating additional and ongoing services
- Analyse and respond to consultations and proposals on regulatory matters in appropriate area of specialisation to ensure views are promoted
- Advise and guide members with the development of compliant packaging
- Liaise as appropriate with other trade associations, including European Self Care Industry association AESGP
- Deputise for other members of the Regulatory affairs team as appropriate
- Support the provision of technical support, including the preparation of briefing documents for MPs, and Government organisations or officials.
- Organise the collation of data from members for submission to MHRA and other stakeholders.
- Represent at government agency meetings as required e.g. FSA, MHRA Industry Group
- Develop and maintain relationships and trust with external contacts and members
Skills and Experience:
- Life sciences, chemistry or pharmacy graduate to honours level or equivalent.
- Experience of assessing evidence, providing analysis and insight
- Experience of working within healthcare, the pharmaceutical industry or in Regulatory Affairs
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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