Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low
Job Overview:
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.
Key Stakeholders: Internal
Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Management
Key Stakeholders: External
Country Distributors, Health Authority (HA), CMOs and external partners
Reporting Structure:
Regulatory Affairs Labeling Manager
Experience:
4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred)
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 a plus
Key Role & 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 labeling
- 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
B. Pharma/ M. Pharma
