Executive Labelling - Regulatory Affairs

Requirements

• 4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred)
• Roles and Responsibilities:
• Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions
• Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and query solving.
• Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labelling
• Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA
• Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs
• Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates
• Contribute to the development and/or review of all labeling aspects included in Promotional Material. Development and maintenance of a central repository for all labeling components
• Competencies
• Must have solid interpersonal and organization skills for interfacing with others.
• Knowledge of Health Authority labeling regulations and requirements.
• Self-directed, motivated, organized, flexible and accountable.
• Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment.
• Project management skills is a plus

Benefits

Additional Information

Be the First to Apply Division Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs. For more details, please visit https://www.piramalcriticalcare.com/global/ Job Title Executive Labelling - Regulatory Affairs Job Description Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Key Stakeholders - Internal: Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team Key Stakeholders - External: Country Distributors, Health Authority (HA), CMOs and external partners Reporting Structure: Directly reports to Manager - Labelling Essential Qualification: Bachelor' degree or Master's degree in Pharmaceutical sciences or equivalent

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