Regulatory Affairs Associate

About the role

As a Regulatory Affairs Associate you will support Douglas in gaining and maintaining product approvals across global markets. You will work closely with product development, quality, commercial and technical teams to ensure our healthcare solutions reach patients safely and compliantly.

Key responsibilities

• Prepare regulatory dossiers and supporting documentation for product registrations and approvals.
• Assist with regulatory responses to health authorities and customers, ensuring accurate and timely submissions.
• Support product renewals, annual reports, regulatory commitments and post‑approval change activities.
• Review change controls, quality investigations and product documentation to ensure compliance with registered details.
• Partner with cross‑functional teams to support product launches and accelerate time to market.
• Maintain regulatory databases, documentation systems and application tracking records.
• Research and monitor regulatory requirements across target markets to support business objectives.
• Contribute to continuous improvement initiatives, regulatory procedures and best‑practice ways of working.

Required profile

• Tertiary qualification in Science, Pharmacy or a related discipline.
• Minimum three years’ experience in regulatory affairs within the pharmaceutical or a similar industry.
• Strong written communication skills with the ability to produce clear, accurate regulatory documentation.
• Excellent attention to detail and a commitment to quality and compliance.
• Experience working with cross‑functional teams in a regulated environment.
• Ability to manage competing priorities while maintaining accuracy.

Required skills

• Regulatory dossier preparation
• Regulatory database management