Senior Regulatory Affairs Associate

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A biopharmaceutical company in Cambridge is seeking a Senior Regulatory Affairs Associate to manage U.S. labelling and artwork activities. You will ensure compliance and accuracy in product labels, contributing to regulatory submissions. The role requires a Bachelor's degree and 3-4 years of regulatory experience. Competitive salary and flexible working hours offered.

Benefits

Competitive salary

Flexible working hours

Performance based bonus

Company pension scheme

100% employer paid membership for Private Health Insurance

Life and Critical Illness Insurance

Corporate Gym membership

Qualifications

• 3 - 4+ years of regulatory affairs experience with a focus on artwork and labelling.
• Experience with US-FDA regulations is preferred.
• Proven ability to work autonomously and collaboratively.

Responsibilities

• Manage U.S. labelling and artwork activities for Cycle products.
• Prepare, review, and approve labelling documents.
• Lead the preparation of ANDA/NDA submissions.

Skills

Regulatory affairs experience

Proficiency in Adobe Illustrator

Excellent written communication skills

Strong project management skills

Attention to detail

Ability to interpret complex information

Education

Bachelor's degree in life science

Tools

Adobe InDesign

Job description

Senior Regulatory Affairs Associate

Job Title: Senior Regulatory Affairs Associate

Company: Cycle Pharmaceuticals Ltd

Position Summary: This is a full-time position within the Regulatory Affairs Development department, working in our Cambridge office on a hybrid basis (minimum 3 days in the office).

The Opportunity

Ready to take the lead in shaping compliant, impactful product labelling and artwork for our product portfolio? As our Senior Regulatory Affairs Associate, you'll put your sharp eye to work, ensuring every product label is current, compliant, and reflects the latest safety updates with absolute accuracy.

You'll support with day-to-day labelling activities as well as contributing to the preparation of labelling sections for FDA regulatory submissions. Having the opportunity to participate in a range of company projects, you will leverage your transferable skills to make a real difference to our growth plan and patients we support.

Strong problem-solving skills and collaboration are key in this position as you'll interact with multiple departments in the business including Quality, Marketing, Compliance, Legal and Project Management. Externally, you'll build strong relationships with CMO's, Distributors, Business Partners and the FDA.

Our Company

At Cycle Pharmaceuticals, we believe that Every Single Patient Matters. This is at the heart of why we work. As we look to grow, we're now 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 core focus areas include rare metabolic, immunological, and neurological 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.

If you want to know more about what we do then, why not check out our website below and look at some of our patient stories:

Patient Stories - Cycle Pharma

What you will be doing:

• Manage U.S. labelling and artwork activities for Cycle products, ensuring accuracy, compliance, and timely updates, with support from the line manager where needed.
• Prepare, review, and approve labelling documents, artwork files, and print proofs to ensure precision and regulatory compliance.
• Contribute to or lead the preparation of ANDA/NDA submissions and the Company Core Data Sheet from a labelling perspective.
• Oversee all labelling activities for successful U.S. product launches and portfolio updates.
• Perform periodic reference product PI checks, manage labelling databases, and ensure ongoing compliance.
• Coordinate and implement labelling changes with cross-functional teams, identifying risks and proposing timely solutions.
• Manage promotional material submissions to the FDA and prepare labelling-related sections of regulatory dossiers and submissions.
• Lead the preparation, review, and approval of packaging artwork, collaborating with internal teams and external partners.
• Create, revise, and finalise labels, cartons, and leaflets for new and existing products, ensuring regulatory, branding, and quality standards are met.
• Coordinate artwork updates for third-party products to reflect Cycle branding elements.
• Maintain version control and documentation for all artwork in internal systems.
• Apply technical expertise in Adobe Illustrator and other design tools to produce high-quality, print-ready artwork.
• Troubleshoot artwork issues and lead process improvements to increase efficiency and accuracy.
• Support continuous enhancement of labelling and artwork processes, tools, and SOPs.

What will enable you to thrive:

The following skills and experience will be important in helping set you up to succeed and thrive in this role.

• Bachelor's degree or above in a life science related degree.
• 3 - 4+ years of regulatory affairs experience with a focus on artwork and labelling.
• Experience with US-FDA regulations is preferred.
• Proficiency in Adobe Illustrator or Adobe InDesign is desirable; alternatively, experience in another platform producing regulatory-compliant artwork.
• Ability to interpret and summarise complex scientific and technical information with clarity and accuracy.
• Excellent written and verbal communication skills and confident at building strong working relationships.
• Highly motivated and enthusiastic with a flexible 'can do' approach.
• Proven ability to work both autonomously and collaboratively in cross-functional teams.
• Strong project management skills, able to manage multiple priorities and meet tight deadlines.
• Results-driven with a proactive, solutions-focused mindset.
• Highly organised, analytical, and skilled in problem-solving.
• Quality-focused with exceptional attention to detail.

What makes this role special

• Seek to have a profound impact on patients and their families.
• Work across a range of different disease states.
• Mentoring, coaching and training that will give you the opportunity for personal and professional development.
• Work with a growing team of experienced professionals.

What we can offer you:

• Competitive salary based on experience
• Flexible working hours with core hours 10am - 4pm
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Corporate Gym membership
• Regular team building events and an agile working environment

Diversity and Inclusion statement:

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.