Job Title: SENIOR MANAGER, REGULATORY INTELLIGENCE AND COMPLIANCE
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Vacancy details
Vacancy description:
Job Code:
J886576
Job Title:
SENIOR MANAGER, REGULATORY INTELLIGENCE AND COMPLIANCE
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
SENIOR MANAGER, REGULATORY INTELLIGENCE AND COMPLIANCE
An excellent opportunity to work with a top global Pharmaceutical company who are currently developing a number of diverse and exciting products. Working within this large company will be an fantastic opportunity to broaden your experience, and is a fantastic chance for you to take your next step up the career ladder!
ROLE DESCRIPTION:
Reporting to the Associate Director for Submissions in Regulatory Affairs your main purpose will be to provide a Regulatory Information and Intelligence service to European based staff. You will also be working to develop the global Regulatory Intelligence function. Additionally you will be expected to identify changes within the Regulatory environment which impact company processes and procedures and to co-ordinate the updating of these procedures and training plans for regulatory colleagues as well as other departments
MAIN DUTIES AND RESPONSIBILITIES:
* Lead local monitoring of changes within the European regulatory environment and communicate changes to the European regulatory affairs departments and to other development colleagues.
* Alert colleagues to changes occurring in other regions which may affect global development plans.
* Provide information on appropriate directives and guidelines to International Project Teams as projects require, to appropriately guide research and development activities.
* Interpret Directives and Guidelines to ensure appropriate and timely development activities within the clinical team.
* Develop materials to assist colleagues with understanding relevant legislation and guidelines.
* Manage and optimise the organisation and storage of regulatory intelligence materials.
* Lead on required changes to internal SOPs arising from changes in legislation or guidelines.
* Co-ordinate the updating of regulatory colleague SOP training matrixes
* Build relationships with regulatory intelligence colleagues throughout the world.
* You may be required to assist in the review and QC of Regulatory Submission component documentation prior to publishing and printing.
* You may be involved in suggesting training requirements for new regulations for regulatory and other internal staff.
ESSENTIAL QUALIFICATIONS AND EXPERIENCE:
* BSc or higher in Life Sciences
PLUS
* Extensive Regulatory Affairs Experience, and a sound understanding of current Regulatory Affairs
* Relevant experience in the provision of a quality information service to all levels of staff.
* Willing to travel occasionally throughout Europe and other regions.
DESIRED SKILLS AND QUALIFICATIONS:
* Experience co-ordinating SOPs would be desireable (not essential)
* Information Science degree (helpful but not essential)
* Strong desk research skills
* Must have good written and oral communication skills
* Strong presentation skills, able to be persuasive.
* Good eye for detail, critical and analytical.
* Strong team player (but ability to work under their own initiative)
* Able to form strong cross-functional relationships
* Flexible
* Proactive to the point of looking to become involved in identifying regulatory issues
* Able to work well under pressure
* Highly organised
* Innovative
* Self Motivated
Key Words: Senior Regulatory Intelligence and Compliance Regulatory Manager Senior Regulatory Manager Regulatory Affairs Hertfordshire Middlesex Essex Buckinghamshire Surrey Berkshire Bedfordshire UK Anywhere South South East
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