Regulatory affairs associate

Full time in Pharmaceutical Email Job

Job Detail

  • Job ID 35464
  • Experience level  Entry level

Job Description

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.

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 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.

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

  • 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.

Required Skills

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