Regulatory Affairs Associate

Full time
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Job Details

Employment Type

Full time

Salary

0.00 USD

Valid Through

Aug 24, 2025

Job Description

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. ResponsibilitiesPrepare 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. RequirementsBachelor’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.

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