Senior Regulatory Affairs Associate – EU, Remote-First

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

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.