Senior Regulatory Affairs Associate

Park Street People; Cambridge; Hybrid; GBP 60,000 - 76,000; Full time

Job summary

Park Street People is looking for a Senior Regulatory Affairs Associate to join a global pharmaceutical client in Cambridge. You will provide regulatory guidance across the EU region and ensure timely preparation of regulatory documents for trials and medical products.

The role is remote-by-design with occasional travel to the nearest office for key meetings, and you will help align development with global regulatory requirements and liaise with agencies.

Qualifications

• Previous experience in Regulatory Affairs and Compliance particularly within pharmaceutical industry.
• Proven background working on CTAs (clinical trial applications) and MAAs (marketing authorisation applications).
• Exposure to Regulatory Affairs legislation and procedures.
• Strong communication and interpersonal skills.

Responsibilities

• Develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
• Contribute regulatory guidance to enhance product development.
• Ensure that product development is aligned with the company’s strategy, business model and global regulatory requirements.
• Act as a point of contact between the company and regulatory agencies while conveying important information.

Skills

Regulatory affairs

Compliance

Clinical trials

CTAs MAAs

EU regulatory requirements

Job description

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.