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 requires meticulous adherence to labeling processes, ensuring compliance with innovator labeling, internal and external partners, and GMP standards. The position involves working within a cross-functional team to ensure labeling documents and change requests are medically and scientifically accurate, regulatory compliant, and aligned with global regulations.
Key Stakeholders:
Reporting Structure:
Reports to the Regulatory Affairs Labeling Manager
Experience:
4 years of relevant regulatory experience, with global exposure including US, EU, and major Rest of World markets preferred.
Competencies:
Key Responsibilities:
Qualifications:
About Us:
Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global provider of hospital generics and the third-largest producer of inhaled anesthetics. Committed to delivering critical care solutions, PCC operates in over 100 countries, with a rich product portfolio including inhalation anesthetics like Sevoflurane, Isoflurane, and Halothane, as well as Intrathecal Baclofen therapy for spasticity management.
With state-of-the-art manufacturing facilities in the US and India, PCC has passed rigorous inspections by regulatory bodies such as the US FDA and UK MHRA. The company’s global workforce of over 400 employees is dedicated to expanding PCC’s footprint through new product innovations.
Piramal Group emphasizes corporate social responsibility, partnering with various organizations to support those in need and to 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. Employment decisions are based on merit and qualifications, and we ensure equal opportunities in all personnel matters, including reasonable accommodation for qualified individuals with disabilities and needs related to religious observance or practice.
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