Regulatory Affairs Associate, Labelling

United States Digital Space LLC; Town Of Cambridge; Hybrid; AUD 70,000 - 79,000; Full time

Benefits offered by this job

Company pension scheme

Private Health Insurance

Life Insurance

Critical Illness Insurance

Gym membership

Team-building events

Flexible hours

Hybrid work model

Job summary

Cycle Pharmaceuticals Ltd is seeking a Regulatory Affairs Associate, Labelling to join our Cambridge team on a hybrid basis (minimum 3 days in the office). You will support day-to-day labelling activities and help maintain product labelling across markets.

Ideal candidates have a life sciences degree and at least one year in Regulatory Affairs or artwork creation, with attention to detail and strong communication skills.

Qualifications

• Bachelor’s degree in life sciences or related subject.
• At least one year’s experience in Regulatory Affairs, labelling or artwork creation.
• Familiarity with US FDA and MHRA regulatory agencies; others helpful.
• Strong attention to detail with regulatory documents and scientific information.
• Good written and verbal communication skills for cross-team collaboration.
• Proactive, organized and reliable with ability to manage several tasks and deadlines.

Responsibilities

• Support preparation, review and maintenance of product labelling and artwork (labels, cartons, leaflets, artwork files, print proofs).
• Coordinate labelling updates across Cycle’s portfolio with focus on US FDA and UK/MHRA considerations.
• Review labelling materials for accuracy, consistency, and regulatory compliance.
• Support regulatory submissions by preparing, checking and maintaining labelling documentation.
• Manage version control, approval tracking and record keeping for labelling/ artwork.
• Collaborate with Regulatory Affairs, Quality, Medical Affairs, Compliance, Product Development, Supply Chain, Legal and external partners to deliver changes on time.

Skills

Attention to detail

Effective communication

Regulatory familiarity

Organized and proactive

Team collaboration

Task management

Education

Bachelor’s degree in life sciences or related subject

Job description

Regulatory Affairs Associate, LabellingCycle Company:

Cycle Pharmaceuticals Ltd

Position Summary:

This is a full-time position within the Regulatory Affairs team working in our Cambridge office on a hybrid basis (minimum 3 days in the office).

Salary: £37,000 to £42,000 depending on experience, plus bonus and benefits.

Join our Regulatory Affairs team as a Regulatory Affairs Associate, labelling where you'll have the opportunity to develop your experience in one of the most important parts of our business bringing medicines to patients through clear, accurate and compliant product information.

In this role, you’ll support day-to-day labelling activities across Cycle’s product portfolio, helping prepare, review, maintain and update product labelling and artwork for different markets. You’ll work closely with colleagues across Regulatory Affairs, Quality, Medical Affairs, Compliance, Product Development, Supply Chain, Legal and Project Management, as well as external partners.

This is a great opportunity for someone early in their regulatory affairs career who enjoys detail, accuracy and coordination, and wants to build specialist expertise in labelling across areas including metabolic, immunology, oncology and neurology.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma

What you’ll be doing in this role:

• Supporting the preparation, review and maintenance of product labelling and artwork, including labels, cartons, leaflets, artwork files and print proofs.

• Helping to coordinate labelling updates across Cycle’s portfolio, with a particular focus on US requirements with the FDA and relevant UK/MHRA considerations.

• Reviewing labelling materials for accuracy, consistency and compliance with approved product information and regulatory requirements.

• Supporting regulatory submissions by preparing, checking and maintaining labelling-related documentation.

• Managing version control, approval tracking and accurate record keeping for labelling and artwork activities.

• Working closely with Regulatory Affairs, Quality, Medical Affairs, Compliance, Product Development, Supply Chain, Legal, Project Management and external partners to ensure labelling changes are delivered accurately and on time.

Skills and experience required:

• A bachelor’s degree in life sciences or a related subject.

• At least one year’s experience in Regulatory Affairs, labelling or artwork creation.

• Some familiarity with regulatory agencies such as the US FDA and MHRA; experience with other non-US regulators would be helpful.

• Strong attention to detail and the ability to work accurately with regulatory documents and scientific information.

• Good written and verbal communication skills, with the confidence to work with different teams and external partners.

• A proactive, organised and reliable approach, with the ability to manage several tasks and meet deadlines.

• A genuine interest in developing specialist expertise in regulatory labelling.

What can we offer to you:

• Competitive salary based on experience.

• Flexible core working hours of 10am to 4pm and hybrid working.

• A collaborative, high-performing work environment.

• Performance-based bonus.

• Opportunity to join a fast-growing and ambitious business.

• Company pension scheme.

• 100% employer-paid Private Health Insurance.

• Life and Critical Illness Insurance.

• Corporate gym membership.

• Regular team-building and social events.

Diversity and Inclusion

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.