Regulatory Affairs Manager

Group Leader Regulatory Affairs - Regulatory Affairs Manager

Hybrid role - access to West London 2-3 days per week as needed.

Product portfolio - A portfolio of branded generic pharmaceuticals within the respiratory space. The products have an excellent price point but also have a fantastic sustainability / environmental angle allied with several clinical and commercial differentiators that form a compelling argument for use.

Company - A GLOBAL Pharmaceutical company with branded and generic solutions. Established over 85 years the business has a turnover more than £2 billion and a real focus on corporate responsibility and sustainability.

Role

The Group Leader Regulatory Affairs - Regulatory Affairs Manager will manage a TEAM (remotely) of three RA professionals. They will act as the focal point for all UK and EU MAA submissions and be responsible for ensuring all Regulatory Affairs matters are successfully dealt with to conclusion. It is key to note that this role will have a VERY broad remit and the appointed person will be asked to lead on all RA issues for the UK and Europe - the scope of the role will include -

• Regulatory Strategy
• Ownership of submissions and reviews of all associated documentation for EMA and MHRA approvals
• Maintenance of Authority throughout product life cycle /. Maintenance of marketing authority validity
• Reporting of variations, renewals
• Delivery of CMC regulatory strategy
• Support of broad business operations / stakeholder management for all RA issues -working closely with EU Country Managers, Supply Chain, Local QA and Business Development teams
• Pharmacovigilance
• Training, support, and development of the team

The Group Leader Regulatory Affairs - Regulatory Affairs Manager will be expected to work on all aspects from strategy through to implementation and have the broad skills and knowledge to ensure successful outcomes.

Applicant Profile -

• Candidates will have 5-6years minimum working in a senior RA role in the pharmaceutical space.
• Candidates will have broad scope RA experience and be able to take ownership for EU and UK MAA submissions.
• Candidates will have experience with variations and renewals within an RA function.
• Management experience is required - as is exceptional stakeholder management skill
• It is key that candidates can take ownership and have a can do /will do attitude - the appointed person will be responsible for RA success and needs to thrive in a diverse role.
• Successful candidates will be problem solvers - innovative and like having ownership and responsibility!

It is essential all candidates for this role are dynamic, self-starting, collaborative and want to take ownership!

To apply for this - or any of our exciting opportunities in the medical devices sales market - Apply Online

·Progress Sales Recruitment is a specialist medical recruitment consultancy dedicated to offering client and applicants alike the highest levels of service. With over 8 years’ experience in recruitment we specialise in the following areas of work - Nurse Advisers, Clinical Specialists, Theatre Sales Specialists, Sales Executives, Business Development Managers, Team Leaders, Sales Managers, Sales Directors and all other sales focused roles within the medical sector. Our core therapy areas include Vascular, Endoscopy, Urology, Neurology, ENT, Infection Control, Anaesthesia, Blood Products, Diathermy, Infusion, Orthopaedics, Surgical Instruments and all PCT, Primary, Secondary, Theatre and Rehabilitation products.