Senior Regulatory Affairs Associate

Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Affairs Associate to join their team in Cambridge. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

Roles are typically remote-by-design but candidates do need to be prepared to travel to their nearest office on occasions for key meetings.

Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory guidance across the EU region and make sure that regulatory deadlines and approvals are achieved (previous EU exposure is preferred).

Other responsibilities include:

• You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
• Contributing regulatory guidance in order to enhance product development.
• Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements.
• Acting as a point of contact between the company and regulatory agencies whilst pertaining important information.

Requirements

• Previous experience in Regulatory Affairs and Compliance particularly within pharmaceutical industry.
• You will have a proven background working on CTAs (clinical trial application) and MAAs (marketing authorisation application)
• Exposure of Regulatory Affairs legislation and procedures
• Strong communication and interpersonal skills

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.