Cache of job #14025921

Job Title

Regulatory Affairs Officer

Employer

ICDS Recruitment

Location

Waterford

Description

Regulatory Affairs Officer- Waterford. Key Purpose: The ideal candidate will support the Scientific Affairs Department in activities associated with the registration of products to trade markets including the EU, US and Japan, as well as Regulatory compliance Department with QA for products. The role includes regulatory activities associated with both human and veterinary new drug developments as well as generics. You will also be required to support activities for running Bioequivalence and Clinical safety and efficacy studies. This role Reports to Senior Regulatory Affairs Officer or Manager. Key Responsibilities: Licence maintenance support to customers. Regulatory Compliance liaison with QA. Support licensing activities for existing Marketing Authorisation applications various markets. Dossier preparation for submission to target markets, including liaison with R&D, QC, and Production as well as external experts where required. Strategic planning of regulatory activities in target markets for products. Qualifications & Experience: Minimum B.Sc. or a third level qualification required, preferably in Chemistry, Pharmacy or Pharmacology. Previous pharmaceutical experience required with 1-2 years in regulatory affairs experience being desirable. Skills: Familiarity with cGMP and cGCP in pharmaceutical manufacturing. Familiarity with EU and US Clinical trials legislation. Familiarity with concepts of Regulatory Approval process for both new drug developments and human generic pharmaceutical products. Technical knowledge of analytical/formulation development of pharmaceutical products. Ability to understand complex clinical terminology and to learn new clinical research skills though working with internal and external experts. Ability to assist in design and management of PK/bioequivalence and efficacy studies. Working knowledge of EDMS. Competent in the use of Microsoft Office. This job originally appeared on RecruitIreland.com.

Date Added

1774 days ago

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