Join Parexel as a Senior Regulatory Affairs Associate- Labeling

Join us as a Senior Regulatory Affairs Associate to coordinate artwork approvals, manage changes, and maintain trackers. Ensure up-to-date PDFs and liaise with teams for seamless implementation.

Senior Regulatory Affairs Associate- Labeling

India- Bengaluru-Remote
India- Bengaluru
India- Chandigarh-Remote
India- Mohali-Remote
India- Hyderabad-Remote

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.

Job Description-

• Must have  4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.

• Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)

• The ability to research and create comparator labeling documents.

• Strong understanding and experience creating annual reports.

• The ability to collaborate with Tech Ops for artwork implementation.

• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.

• Electronic document management systems use and / or electronic submission experience.

• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.

• Must have handled CCDS related submission / safety variations / PSUR / xEVMPD / Label and artwork updates.

• Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.

• Monitor, manage and control artwork changes.

• To manage and maintain the Artwork Trackers & Systems.

• To ensure artwork PDF’s are maintained and latest versions are readily available.

• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved