Position: Regulatory Affairs Senior Manager/Associate Director
Based in Central London
Competitive salary and generous benefits
About the role
This is a new position within an expanded regulatory affairs team. The successful candidate will lead on the development and delivery of PAGB’s regulatory strategy for medicines, medical devices and food supplements. As an expert in OTC regulation, with extensive experience in the consumer healthcare industry, you will coordinate the delivery of day to day regulatory support to PAGB members; manage PAGB working groups and sub-groups and their work programmes; and work with colleagues on PAGB’s response to regulatory and scientific issues affecting its members.
You’ll confidently develop and maintain relationships with relevant external stakeholders in pursuit of PAGB policy objectives such as government organisations, regulators, trade associations in the UK and, where appropriate, Europe ensuring that PAGB’s position is represented.
Qualifications and experience
- Educated to degree level in relevant science-based subject
- At least 7 years significant regulatory experience in the OTC industry
- Good understanding of the regulatory and pharmaceutical environment. Having commercial and strategic awareness.
- Significant industry experience in regulatory affairs, preferably in the consumer health sector for example, preparing regulatory submissions Marketing Authorisations, Reclassifications, responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines, managing and maintaining Marketing Authorisations.
- Regulatory knowledge of medical device certification preferable.
- Experience of authoring and report writing.
- Project management.
- Proven successful interaction with the Regulatory Authorities.
- Experience of authoring, implementation and training of internal processes.
What we’re looking for in this role
- Able to motivate a team and support them through change
- Able to analyse complex data to determine the key facts and to be able to communicate these at the right level for the audience.
- Problem solving skills, methodical, pragmatic, logical with technical aptitude
- Good organisation, planning, able to prioritise
- Can work under pressure to achieve deadlines
For additional information about the application process, please contact Pauline Young, HR & Administration Manager on 020 7421 9312 or email email@example.com