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Senior Regulatory Affairs Officer, Respiratory and EU Reg Exp.
Posted: 27/06/08
Recruiter:1st-itpeople.com
Reference:360721
Type:Permanent Vacancy
Language:
Salary:£35000 per annum + 25 days hol and full benefits
Benefits:
Location:Essex
Description:
Accountabilities/Responsibilities:

-Making sure regulatory approvals are secured for defined products/ projects.

-Providing regulatory support/ resource to project teams for defined products.

-Supporting the development, implementation of review of regulatory strategies for defined projects.

-the effective supervision of regulatory professionals and administrative support staff.

-The preparation, compilation, review and submission of high quality regulatory dossiers in accordance with the EU/US requirements for legislation.

-Co-ordinating the preparation and conducting the review of responses to questions raised by the regulatory authorities.

- Co-ordinating regulatory resource to projects and providing technical regulatory support to individual projects.



Essential Skills & Capabilities:

-Minimum Qualifications/ Experience

Minimum of 3 years regulatory experience.

Member of TOPRA

Scientific degree or equivalent qualifications



-Knowledge

Coaching and supervisory experience



-Skills

Excellent verbal and written communication skills

Management and supervisor training.

Time and organization management training



-Competencies

Initiative, Analysis, Teamwork, Tenacity, Diplomacy