regulatory affairs manager (europe) in leatherhead

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leatherhead, south east
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Regulatory Affairs Manager - Europe

Location: Leatherhead, Surrey

Job Type: Permanent

Salary: £55,000 per year

An exciting opportunity to work as a Regulatory Affairs Manager in an Pharmaceuticals company.

Job Purpose:

* To support the Global Regulatory Affairs management in:
* Keeping up to date with regulatory and legal changes in major markets
* Preparation of documentation to support marketing authorisation applications
* Preparation of post authorisation regulatory documentation and applications, including market access and ethics committee applications
* Regulatory submissions for clinical programs including ethics committee approvals
* Labelling and packaging material supply
* Orphan drug designation activities (EU, CH and USA) - Provision of general regulatory advice to staff.

Key Competencies

* Proven ability to plan, organise and follow up with a minimum of supervision
* Excellent working knowledge of European regulatory requirements
* Good working knowledge of international regulatory standards
* Ability to work in English, French and German preferred
* Excellent attention to detail
* Research skills (ability to source, review and summarise information)
* Effective verbal and written communication in individual and group settings
* Ability to create and maintain relationships with internal/external customers
* Ability to work in a team environment
* Problem solving skills
* Effective time management of multiple tasks
* Negotiation skills
* Presentation skill


* Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline.

Randstad Business Support is acting as an Employment Agency in relation to this vacancy.