Regulatory Affairs Associate – Labeling VAR Coordination
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Job Description
Regulatory Affairs Associate managing product labeling ensuring compliance with regulatory requirements at Parexel. Supporting marketing authorization submissions and collaborating with cross-functional teams for labeling accuracy.
Responsibilities:
- Responsible for managing labeling ensuring compliance with regulatory requirements
- Support marketing authorization submissions, lifecycle management, and post-approval variations requiring labeling updates
- Prepare, review, and update product labeling according to requirements from Health authorities
- Ensure localized labeling content complies with each country’s standards
- Coordinate artwork development and version control with internal teams and external vendors
- Support Marketing Authorization Applications (MAAs), renewals, and variations that involve labeling changes
- Prepare labeling sections of the dossier per local format
- Work closely with RA, QA, supply chain, artwork teams, and local affiliates to ensure labeling accuracy and timely updates
- Act as liaison between global teams and local representatives
- Build networking within the industry and maintain client relationships
Requirements:
- Initial years of experience in an industry-related environment
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language
- Minimum of a bachelor’s degree in a Scientific or Technical Discipline
Benefits:
- Health insurance
- Professional development opportunities
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