Remote jobs in regulatory affairs at PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Senior Regulatory Affairs Associate (Labelling)

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

Regulatory Submissions and Documentation:
• Experience with PSUR submissions
• Handling of CCDS-related submissions, safety variations, and xEVMPD
• Ability to research and create comparator labeling documents
• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.

Label and Artwork Management:
• Coordination of artwork approval process for printed packaging components
• Ensuring compliance with packaging design and legislation requirements
• Experience in label and artwork updates for new products, packs, or changes

Technical Skills and Adaptability:
• Proficiency in relevant software and systems for labeling management
• Ability to handle multiple projects and adapt to changing regulatory environments
• Strong attention to detail and excellent communication skills

Location:
India-Bengaluru-Remote
India-Bengaluru
India-Chandigarh-Remote
India-Mohali-Remote
India-Hyderabad-Remote
India-Mumbai-Remote