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Vacancy details
Vacancy description:
Job Code:
J620836
Job Title:
Regulatory Affairs Associate - Surrey
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
QA, Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire, Hampshire, Surrey
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
15 Aug 2008
Working as a core member of the central regulatory team, you will input into the commercial products of this TOP GLOBAL Pharmaceutical company. The portfolio includes a mix of development projects and post approval activity.The department, which has a proven track record of leading switch activity on multi million pound brands, is fast paced delivering innovative self-medication products to the market, where speed to market and flexibility is key.
The right candidate will have an opportunity to make and influence decision making on regulatory issues that impact the European commercial agenda, whilst working closely with commercial colleagues, and multidisciplinary project teams at all levels.
As a Regulatory Affairs Associate, you will:-
• Collaborate closely with multi-disciplinary teams, relevant business groups and other company functions as appropriate, and provide sound regulatory advice for assigned projects and products.
• Liaise with local market regulatory teams to ensure the central strategy meets local needs, as well as providing support to commercial and market internal customers.
• Support regulatory aspects of product life-cycle management for assigned products, including management of core labelling.
• Co-ordinate and manage the preparation, content and format of high quality core data packages, liaising with data generating groups (internal and external) as relevant.
• Co-ordinate and manage ( the preparation of responses/position papers for regulatory authorities.
• Be required to keep up-to-date with EU medicines/devices legislation and provide interpretation, as necessary, on potential project/product impacts to regulatory affairs and other departments.
• Gain and maintain an awareness of key aspects of regulation in the European Union and elsewhere.
• Provide proposals for resolution of regulatory issues.
• Participate in specific process improvement projects.
Basic Requirements:
Degree qualified in a physical or life science.
• Basic working knowledge of European regulation of at least one of the following:
1. Medicinal products
2. Medicinal devices
• Commercially aware with an appreciation of commercial and supply chain pressures and issues.
• Experience of working flexibly across a portfolio of products and projects;
• Experience of preparation of European regulatory documentation would be useful but not essential, for example;
Abridged MAA regulatory dossiers, variations and renewals for products registered both nationally and via MR/DCP/Centralised
Clinical Trials applications
Medicinal device technical files
• Basic understanding and knowledge of the product development process and associated regulatory processes and procedures
• Good IT skills - knowledge and ability to use appropriate IT software
• Good written and verbal skills including the ability to accurately summarise and communicate regulatory information
• Good organisational skills to plan work such that assigned tasks are completed to agreed timelines.
• Ability to build and maintain effective relationships with technical groups, country regulatory groups and commercial colleagues
• Customer focused, Strong team player
• Awareness of and ability to work within areas of cultural differences
• Proactive attitude to process improvement and best practice
Experience of European non-prescription medicinal products and/or devices
• Development of simple regulatory strategies
• Experience of working flexibly across a portfolio of projects running concurrently.
• Awareness of regulatory processes in EU markets.
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