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
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Parexel Regulatory Affairs Job Vacancies - Senior Regulatory Affairs Associate[/caption]
How to Apply: Interested candidates can apply for the Remote Senior Regulatory Affairs Associate position at Parexel through the official job listing
https://pharmastuff.org.in/job/parexel-hiring-remote-senior-regulatory-affairs-associate
