Senior Associate Regulatory Affairs

Planet Pharma; Cambridge; Hybrid; GBP 42,000 - 54,000; Full time

Job summary

Planet Pharma seeks a Senior Associate Regulatory Affairs to support the development and lifecycle management of pharmaceutical products. You will work with UK & Ireland teams to ensure compliance and successful product approvals in the region.

The role is mainly remote with monthly attendance in Cambridge, offering collaboration with global regulatory leads and exposure to evolving regulatory expectations.

Qualifications

• Broad regulatory affairs experience in UK settings.
• Strong knowledge of regulatory principles and labelling.
• Experience with regulatory submissions and cross-functional teams.

Responsibilities

• Support regulatory submissions and submissions lifecycle.
• Collaborate with global regulatory teams to ensure compliance.
• Contribute to lifecycle management and regulatory strategy.

Skills

Regulatory affairs

UK affiliate experience

Lifecycle management

Regulatory submissions

Cross-functional collaboration

Education

Master’s degree in a scientific discipline

Bachelor’s degree with relevant regulatory experience

Tools

Veeva RIM

Job description

Senior Associate Regulatory Affairs

Join our team as a Senior Associate Regulatory Affairs and play a vital role in supporting the development and lifecycle management of innovative pharmaceutical products. This exciting position offers an opportunity to work within a dynamic regulatory environment, collaborating closely with global teams to ensure compliance and successful product approvals in the UK & Ireland. Based mainly remotely in Cambridge, you will contribute to impactful projects that support patient health while developing your career in regulatory affairs.

What You’ll Need to Succeed

• Broad regulatory affairs experience, particularly within a UK affiliate setting, covering clinical trials, post-marketing, lifecycle management, and labelling.
• Strong knowledge of regulatory principles, SOPs, and policies related to medicinal products.
• Excellent communication skills, capable of liaising with regulatory agencies and cross-functional teams.
• Familiarity with local legislation, and ideally, experience using Veeva RIM.
• Ability to manage multiple tasks efficiently, supporting regulatory submissions and compliance activities.

Nice to Have

• Experience with Veeva RIM or similar regulatory information management systems.
• Previous involvement in regulatory activities related to urgent safety communications or agency commitments.
• Additional knowledge of national legislation affecting pharmaceutical regulations in the UK & Ireland.

Preferred Education and Experience

• Master’s degree in a scientific discipline or Bachelor’s degree with at least 2 years of relevant regulatory experience.
• Current UK affiliate experience is essential, with candidates available to start quickly (within 4 weeks preferred).

Other Requirements

• This is a 12-month contract role with the flexibility of remote work, requiring attendance in Cambridge once per month for team meetings.
• Candidates must be in a UK & Ireland affiliate role at the time of application.
• Ability to work effectively in a collaborative environment, supporting regulatory strategies for low to medium complexity programs.