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 will oversee all artworks and labeling components for Piramal Critical Care products globally. This role ensures adherence to labeling processes, compliance with innovator standards, and alignment with GMP regulations. The position requires active participation in cross-functional teams to ensure that labeling documents and change requests are medically and scientifically accurate, regulatory compliant, and in line with current global regulations.
Key Stakeholders:
Reporting Structure:
Reports to the Regulatory Affairs Labeling Manager
Experience:
4 years of relevant regulatory experience, with a preference for global experience in US, EU, and major Rest of World markets.
Competencies:
Key Responsibilities:
Qualifications:
B.Pharm or M.Pharm
About Us:
Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global producer of inhaled anesthetics and a prominent player in hospital generics. With operations spanning the USA, Europe, and over 100 countries, PCC offers a range of critical care solutions including Sevoflurane, Isoflurane, Halothane, and Intrathecal Baclofen therapy.
PCC boasts state-of-the-art manufacturing facilities in the US and India, which have successfully passed inspections by regulatory authorities such as the US FDA and UK MHRA. The company’s global workforce of over 400 employees is dedicated to expanding PCC’s reach through innovative product development.
In line with Piramal Group's commitment to corporate social responsibility, PCC actively collaborates with partner organizations to provide support and resources to those in need, while also focusing on environmental stewardship.
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 we strive to provide equal opportunities in all personnel matters, including reasonable accommodations for qualified individuals with disabilities and religious practices.
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