Parexel Hiring Remote Senior Regulatory Affairs Associate

opportunity to work remotely as a Senior Regulatory Affairs Associate at Parexel. Learn about the qualifications, responsibilities, and locations available in India, including Remote, Hyderabad, and Mumbai.

About Parexel: Parexel is a renowned consulting firm specializing in helping biopharmaceutical and medical device companies navigate regulatory challenges. Join a dynamic team focused on innovation and collaboration, with opportunities for continuous learning and career growth.

Role Overview: Senior Regulatory Affairs Associate

Qualifications:

• Around 4-8 years of relevant experience in drug product life cycle management
• Good understanding of global regulatory frameworks, including EU/US procedures
• Experience in handling CMC-related queries and submissions
• Working knowledge of Regulatory Information Management Systems like Veeva Vault
• Strong communication and mentoring skills
• Ability to work independently and collaborate effectively with cross-functional teams

Responsibilities:

• 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

How to Apply: Interested candidates can apply for the Remote Senior Regulatory Affairs Associate position at Parexel through the official job listing

Apply Here