Regulatory Affairs Labeling Specialist

📋 Description

• Evaluate the regulatory implications of change controls raised in TrackWise for medicinal products
• Create and maintain product information documentation, including the Company Core Data Sheet
• Prepare and submit regulatory variations, notifications, and renewals, ensuring that documentation
• Review and respond to Health Authority questions related to submissions, coordinating with relevant
• Manage medicinal product labeling updates, including translations, while collaborating with
• Coordinate and maintain post-approval regulatory activities in Veeva Regulatory Information

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related discipline, or equivalent
• At least 6 years of experience in regulatory affairs or regulatory labeling, preferably within the
• Strong understanding of medicinal product labeling requirements, Health Authority submission
• Ability to assess clinical information and apply relevant knowledge when preparing and updating
• Familiarity with Veeva RIMS and TrackWise for regulatory information management, change control
• Experience with the Extended EudraVigilance Product Dictionary (xEVMPD) is an advantage.

🎁 Benefits

• Work remotely from India, with opportunities to collaborate with international teams.
• Access to continuous learning opportunities and the chance to deepen expertise in regulatory
• Gain experience working with international regulatory procedures, Health Authorities, and
• Explore opportunities to broaden your regulatory knowledge and develop your career within a global
• Contribute to the accuracy and compliance of medicinal product information, helping healthcare
• Work alongside experienced professionals in a team-oriented environment that values flexibility