We are seeking a detail-oriented Regulatory Affairs Specialist with 3+ yrs experience in post-approval regulatory activities for medicinal products registered through European procedures (CP, MRP, DCP, and National Procedures). The successful candidate will support lifecycle management activities, regulatory submissions, CMC documentation updates, and health authority interactions while ensuring compliance with applicable regulatory requirements.

Key Responsibilities

- Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.

- Assess regulatory implications of manufacturing, quality, labeling, and product information changes.

- Manage and maintain regulatory change records within Veeva RIMS.

- Support implementation of regulatory strategies for post-approval changes.

- Review, update,



and author Module 3 sections of CTD dossiers for medicinal products.

- Ensure CMC documentation remains current and compliant with regulatory expectations.

- Support dossier lifecycle maintenance activities across multiple markets.

- Conduct comprehensive Gap Analysis of Module 3 documentation.

- Identify compliance risks, data gaps, and documentation deficiencies.

- Develop and recommend remediation plans and regulatory strategies to address identified gaps.

- Manage post-approval regulatory activities throughout the product lifecycle.

- Support maintenance of marketing authorizations across EU markets.

- Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.

📌 Regulatory Affairs Associate (Serilingampalle (M))
🏢 Parexel
📍 Serilingampalle (M)