Regulatory Affairs Officer - Pharmaceutical

Posted 6 April by Search Consultancy Easy Apply

Regulatory Affairs Officer - Pharmaceutical

My client are a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, and active pharmaceutical ingredients.

They have a new opportunity for a Regulatory Affairs Officer within the Regulatory Affairs department. This is a 12 month contract. You will be responsible to collate documents and prepare marketing authorisation applications. Work with cross-functional teams to prepare responses to questions from authorities in a timely manner.

The Role:

* Licence preparation - National, DCP and Mutual recognition
* The preparation of Type II MR Variations
* Submissions to external databases and liaise with user test team
* Clinical Trial Applications collation, submission and responses

The Candidate:

* Candidates will have a degree or equivalent qualification in a science based subject
* Previous experience in a Regulatory Role will be highly desirable
* Experience in the pharmaceutical industry, working to both EU and US GMP requirements would desirable.
* Experience in writing licence applications would be highly desirable
* Experience evaluating written information

Key Words: Regulatory Affairs, DCP, GMP, EU applications, Licence Applications

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.

Required skills

  • GMP
  • Regulatory Affairs
  • DCP
  • EU applications
  • Licence Applications

Reference: 34840844

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