Regulatory Affairs Associate

We’re partnering with a leading global consumer health company to find a Regulatory Operations Medicine Associate who will play a key role in supporting regulatory compliance across a diverse international product portfolio. This is a high-impact, cross-functional role responsible for managing global regulatory submissions, maintaining product dossiers, and ensuring ongoing compliance with European and international health authority requirements.

Responsibilities

• Prepare and submit regulatory documents (e.g., eCTD, variations, renewals) to meet global standards.
• Maintain and update product dossiers; ensure timely submissions and compliance.
• Review and validate artwork text for regulatory accuracy.
• Track deadlines for regulatory changes and manage electronic document archives.
• Support regulatory managers and coordinate across teams and markets.
• Work with teams (e.g., Quality, R&D, Marketing) to ensure product compliance.
• Help improve regulatory processes and contribute to strategy development.

Requirements

• Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field.
• 2+ years in regulatory affairs (pharma or healthcare).
• Knowledge of EMA, ICH, and local regulatory guidelines.
• Experience with eCTD and Module 3 (CMC) review.
• Strong project management, communication, and teamwork skills.
• Detail-oriented and comfortable in fast-paced, cross-functional environments.