Regulatory Affairs Manager Berkshire
Permanent / Maidenhead, UK
Regulatory Affairs Manager Berkshire £50,000
An exciting opportunity has arisen with a leading pharmaceutical company for a Regulatory Affairs Manager. This is a permanent position offering a competitive salary plus benefits package which would provide the candidate a great chance to expand their experience and work with one of Europe's top companies.
- Identify and respond to regulatory and legislative issues that impact the company's ability to approve and maintain its product portfolio in Europe.
- Participate in EU regulatory policy network and deliver cross-functional communication to convey EU policy issues and to ensure one voice policies are developed and kept.
- Line management of 10-15 people
- The EU Regulatory Policy Manager supports development of the company portfolio in Europe and maximises its life-cycle management in the Region.
- Interaction with one of the key decisive EU Regulatory Agencies.
- The role also supports the key area of compliance of marketed products through its impact on new legislation and guidelines and in particular due to the major regulatory role of MHRA in all EU regulatory compliance procedures and activities
- Develop processes/tools to underpin effective information management in relation to EU regulatory policy topics, and to provide regular assessment of external regulatory change and give concise communication on its internal application.
- As a senior member of the UK Regulatory Team, take responsibility for assigned regulatory projects; ensure the quality of submitted documentation in line with statutory requirements and facilitation of UK Health Authority contacts and meetings
- A Bachelors degree (or higher) in a relevant discipline
- At least 5 years' experience in U.K./EU pharmaceutical regulatory activities managing major projects.
- Strong lifecycle management experience
- You will need a sound knowledge of global drug development processes, in particular UK / EU regulatory requirements and process.
- Excellent communication skills with proven influencing and negotiation abilities.
- People management skills are key to this role, working within a global organization with cross-functional teams at a local, EU and Global level.
- Good commercial awareness and knowledge of the therapeutic areas that the company operates within
Key Words: Regulatory Affairs, Reg Affairs, Regulatory Affairs Manager, London, West London, Berkshire, home based, office based, pharmaceutical, Clinical Research Organisation, CRO
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