Regulatory Affairs Associate / Regulatory Affairs Specialist / Regulatory Affairs Manager

Role Description

The Regulatory Affairs Associate / Regulatory Affairs Specialist / Regulatory Affairs Manager supports product submissions, registrations, and lifecycle activities within the relevant industry. Responsibilities include preparing documentation, tracking requirements and deadlines, coordinating responses to authorities, and assessing the impact of product changes.

The Associate maintains records and supports submissions. The Specialist evaluates requirements and manages assigned regulatory activities, while the Manager develops regulatory plans, reviews submissions, leads teams, and coordinates priorities with Quality, Research, Manufacturing, and commercial functions.

Qualifications

• Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a discipline relevant to the products and industry.
• Relevant experience in regulatory affairs, quality, product compliance, or submission support.
• Understanding of product registration, submission documentation, change control, and lifecycle maintenance.
• Ability to research requirements and translate them into clear documentation and actions.
• Strong attention to detail when checking evidence, versions, labelling, and submission records.
• Strong communication and organisational skills for coordinating contributors and deadlines.
• Familiarity with document management systems, submission tools, and regulatory tracking.
• For associate positions, ability to compile documents, maintain registrations, and track outstanding information.
• For specialist positions, experience preparing submissions, assessing changes, and coordinating authority enquiries.
• For manager positions, proven experience setting regulatory priorities, reviewing technical work, managing teams, and overseeing submission delivery.