Job Title: Regulatory Affairs Specialist – Labeling
Department: Regulatory Affairs
Business Unit: Piramal Critical Care
Location: Kurla, Mumbai
Travel: Low
Job Overview:
The Regulatory Affairs Specialist is responsible for managing all artworks and labeling components for Piramal Critical Care products globally. This role ensures adherence to labeling processes and compliance with innovator labeling, internal and external partners, and GMP standards. The position requires collaboration with cross-functional teams to ensure labeling documents and change requests are accurate, meet regulatory standards, and align with global regulations.
Key Stakeholders:
Reporting Structure:
Reports to the Manager – Labeling
Experience:
4 years of relevant regulatory experience, with global exposure including US, EU, and major Rest of World markets preferred.
Key Competencies:
Key Responsibilities:
Qualifications:
Required Skills:
About Us:
Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global player in hospital generics and the third-largest producer of inhaled anesthetics. With a commitment to delivering critical care solutions and maintaining sustainable and profitable growth, PCC operates in over 100 countries. The company’s product portfolio includes inhalation anesthetics like Sevoflurane, Isoflurane, and Halothane, as well as Intrathecal Baclofen therapy for spasticity management.
PCC boasts state-of-the-art manufacturing facilities in the US and India and is dedicated to expanding its global footprint through new product innovations in critical care. The organization values corporate social responsibility, collaborating with partner organizations to support those in need and care for the environment.
Equal Employment Opportunity:
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, gender identity, age, disability, or other legally protected characteristics. We make employment decisions based on merit and qualifications and strive to provide equal opportunities in all personnel matters.
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