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.
* 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
* 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.
- Regulatory Affairs
- EU applications
- Licence Applications