US Regulatory Affairs Scientist - Drugs & Biologics - Boston

Regulatory Affairs Scientist with US experience required to work on drug and biologics projects at a top international consultancy based in the Boston metro.

This is an outstanding opportunity to join a specialist regulatory firm who work consulting start-up to medium-sized biotechnology, pharmaceutical and medical technology companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development.

You will have the chance to work on products including drugs, biologics, medical devices, combination products, advanced therapy products as well as borderline products (food supplements and cosmeceuticals).

Working in an international environment, you will be involved in several projects at which will consist of the design and implementation of product development strategies and in the preparation of regulatory submissions, i.e. Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), CE marking files, Orphan Drug Designations (ODDs), Regulatory Agency meeting packages for medicinal products and medical devices. Daily activities will also include interaction with Regulatory Agencies, regulatory surveillance and reporting to the rest of the team.

For this role you should have experience of the US (FDA) regulatory procedures and a degree in a scientific or health-related discipline. You should have strong client-facing skills and an understanding of the processes which go into new submissions. Ideally you have some knowledge on biologics with cell-gene therapies. You must have basic knowledge of the drug development process and the pre-marketing phases of a medical and biomedical product.

Salary is dependant on experience.

This position, US Regulatory Affairs Scientist - Drugs & Biologics - Boston, was posted on January 26, 2011. The job is located in Boston. Since this job has been published, it has been viewed 28 times.