This role will be based in our state-of-the-art co-working facilities in Moorgate, London; with fantastic amenities and support services including a gym, coffee bar and conference rooms. Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. In Regulatory CMC (Chemistry, Manufacturing and Controls) our experts maintain the scientific and technical aspects of products that ensure patients receive medicines that are manufactured and tested to a high quality and within compliance of the requirements of the worlds Health Authorities.
International Regulatory Affairs CMC is a key component of our companys strategy to build regional CMC regulatory knowledge and effective local relationships with country offices to deliver appropriate regulatory strategies and deliver right first-time regulatory submissions. As part of the EMEA team you will be one of the regional experts for CMC in Europe, Middle East and Africa.
Duties
The Associate Scientist Regulatory CMC will be involved in and responsible for the execution and management of the EMEA region submissions including new product registrations and life-cycle submissions to keep our products compliant and available for patients. In this role you will be working to:
* Generate regulatory strategies
* Assess changes to dossiers in the EMEA region
* Liaise with colleagues globally
* Review submission packages
* Work alongside our team in health authority interactions
* Work alongside our team to deliver on operational excellence projects
* Work alongside our team in developing best practises for regulatory science
* Learn and apply regulatory policy
Requirements
You will be looking to complete a 12-month placement in your penultimate or final year of study, returning to your course at the end of the placement. You will be working towards a BSc in a scientific discipline such as chemistry, biological sciences, engineering, or a related field. Fields of study include (but are not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification). A valid Driving License is also required.
Merck & Co., Inc. is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace.
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