Regulatory Affairs Associate
Parexel International (india) Private Limited
Work from Office
Full Time
Min. 3 yearsJob Description
Regulatory Affairs Associate
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
Experience Level
Mid LevelJob role
Job requirements
About company
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