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Vacancy details
Vacancy description:
Job Code:
J597754
Job Title:
Senior Regulatory Officer
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Our client, a pharmaceutical company based in Berkshire are looking for an experienced individual within Regulatory Affairs. You will have fantastic international exposure, which is also a requirement on application as well as clinical and post marketing experience.
To obtain and maintain regulatory authority approvals for company products internationally.
Key accountabilities and activities:
1. To manage regulatory aspects of specific projects as requested.
This will include:
• Marketing Authorisation Applications
• Clinical Trial Applications
• Variations / Amendments / Notifications
• MAA renewals
• Device Applications, including those to Notified Bodies.
• Communication with regulatory authorities and other organisations
• Correspondence and follow-up within the company group of companies
• Assessment of available data for inclusion in applications
• Establishing and maintaining special files relating to the projects
• Co-ordinating the preparation of responses to authority questions
2. To contribute to the development of the regulatory strategy for designated projects on an international basis
3. To develop project plans for regulatory activities as necessary, to form part of the overall project plan for a compound
4. To represent Global Regulatory Affairs on International Project Teams for development projects and line extensions as required
5. To review and comment on protocols and reports relating to clinical and ocassionally preclinical and CMC development
6. To maintain an up-to-date status of projects.
7. To establish and maintain files as designated.
8. To assist in assessment of in-licensing opportunities as required.
9. To contribute to regulatory intelligence in designated areas of interest.
10. To establish good connections with members of the industry and regulatory bodies
11. To maintain membership of societies and organisations of interest to the company
Travel Requirements:
Occasional trips to EU countries. Occasional trips to US.
Qualifications and experienced required:
• Degree in Scientific discipline (Pharmacy, Chemistry, Biological Sciences)
• Excellent written and oral communication skills
• Ability to distil key information from complex and extensive information sources and present the information in a positive way
• Strong organisational abilities
• Keen eye for detail
Keywords: Senior Regulatory Officer Berkshire international experience post marketing experience
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