Regulatory Affairs Manager UK/EI
London, United Kingdom
| Reference | RWAL23993 |
| Contract type | Permanent |
1) UK/Ireland
Supports the implementation of regulatory operational activities in the UK/Ireland, and provides regulatory support to the registration and post-licensing of EU medicinal products in the UK/Ireland region.
Is responsible for the maintenance of regulatory packaging, tracking systems and regulatory knowledge databases for the UK/Ireland.
Develops and maintains knowledge of UK and IE national regulatory procedures.
2) EU Product Lifecycle Management
Supports the implementation of regulatory strategy in Europe and the EEA and provides regulatory support for the registration and post-licensing activities of medicinal products.
Develops and maintains knowledge of EU regulatory procedures.
Builds and maintains relationships with Regulatory and other staff within and outside the region to ensure effective communication and efficient implementation of regulatory activities.
Desired Skills & Experience
Education and Experience
*Life Sciences Graduate, ideally with post-graduate qualification in a relevant area and/or prior experience in product development functions (pharmaceutical development, toxicology, clinical trials, etc).
*Good knowledge of both national regulations within the UK/Ireland region and European pharmaceutical regulations and guidelines.
*Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within UK/Ireland and/or Europe.
*Experience in cross-functional project teams.
*Conversant with the primary functions of pharmaceutical development, microbiology, toxicology, clinical research and quality assurance.
Essential Skills and Abilities
*Organisational and planning ability
*Negotiation skills
*Excellent communication skills, both written and verbal (in English).
*Ability to work effectively and collaboratively across cultures and cross-functionally.
*Computer literate.
| Expires on | 5/23/13 12:27 PM |
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