Manager – Regulatory Affairs | Piramal Critical Care
Location: Kurla, Mumbai, Maharashtra (On-site)
Work Type: Full-time
Travel: Low
Estimated Salary: ₹20–28 LPA (based on 8–10 years of regulatory affairs experience in pharma)
About the Role:
Piramal Critical Care, part of Piramal Pharma Ltd, is hiring a Manager – Regulatory Affairs to oversee the regulatory portfolio for the USA market. The candidate will manage regulatory submissions, lifecycle maintenance, and post-approval variations while mentoring junior staff and ensuring global compliance.
Key Responsibilities:
Author, review, and manage regulatory submissions to health authorities, distributors, and partners.
Lead dossier submissions for LATAM/ROW markets and manage post-approval variations.
Liaise with internal/external manufacturing sites to assess CMC changes and devise global filing strategies.
Oversee electronic publishing and documentation compilation for product registration and lifecycle management.
Conduct regulatory due diligence for in-licensing and product acquisitions.
Support cross-functional teams in gap analysis, product development strategy, and HA interactions.
Stay current with regulatory guidelines, including ICH, WHO, GMP, USP, and US FDA standards.
Interpret regulations and recommend proactive regulatory strategies.
Required Qualifications:
Master’s degree in Pharmacy (full-time). Certification in Regulatory Affairs is a plus.
8–10 years of experience in regulatory affairs within the pharmaceutical industry.
Expertise in ROW, LATAM dossier submissions, and regulatory strategy execution.
Key Competencies:
Exceptional communication, negotiation, and presentation skills.
Strong command of regulatory documentation, especially CMC sections.
Excellent problem-solving and decision-making ability.
Skilled in Microsoft Office Suite (Word, Excel, PowerPoint, Access).
Critical thinker with a proactive and adaptable mindset.
Strong collaboration and leadership skills to mentor junior staff.
Why Join Piramal Critical Care?
Be part of the third-largest producer of Inhaled Anaesthetics worldwide.
Engage in regulatory affairs with a global product portfolio across 100+ countries.
Work in an ethics-driven, inclusive, and growth-focused organization.
Opportunities to contribute to strategic regulatory development and global expansion.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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