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Job Title: Regulatory Affairs Officer Level 2
Date Posted: May 20.2013
Closing Date: May 29.2013
Summary: An opportunity has arisen to join the Regulatory Affairs team. The role involves performing regulatory activities to support the business in New Product Registrations and maintenance of existing product registrations world-wide
Key Responsibilities
•Preparation of CTA/IND
submissions and maintenance of
documentation
•Preparation of documentation for
high quality submission,
variations, renewals and annual
updates
•Follow up of submissions and
relevant actions
•Work with internal customers to
provide data as required
•Understanding relevant
legislative and regulatory
guidance applicable to activities
at ATL
•Preparation of PSURs
Candidates will have the following attributes:
•Relevant life sciences degree or
minimum of 2-3 years experience
in the pharmaceutical field
•Experience of regulatory
and legal framework
•Demonstrated ability to write
good quality documents
•Highly PC literate
•Interpersonal skills including
good communication both written
and verbal
•Ability to show initiative
and take a problem solving
approach
•Ability to show good attention
to detail and accuracy
A competitive salary is offered in accordance with experience.
Excellent Benefits:
•25 days holiday
•Pension Plan
•Private Health Care
•Life Insurance
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