Regulatory Affairs Job at Piramal | Senior Executive Vacancy for B Pharm & M Pharm
Looking for a Regulatory Affairs Job in the pharmaceutical industry? Piramal Critical Care is hiring a Senior Executive – Regulatory Affairs in Mumbai. This opportunity is ideal for B. Pharm, M. Pharm professionals with experience in regulatory submissions, dossier preparation, and global market compliance who want to build a successful Piramal Career in pharmaceutical regulatory affairs.
- Job Title: Senior Executive – Regulatory Affairs
- Job ID: R00001797
- Job Location: Mumbai, Maharashtra, India
About the Company
Piramal Critical Care, a business unit of Piramal Pharma, is a global leader in hospital generics and inhalation anesthetics. The company serves healthcare providers across more than 100 countries and operates world-class manufacturing facilities approved by international regulatory authorities, including the US FDA and UK MHRA.
Professionals pursuing a Piramal Career gain valuable exposure to international regulatory frameworks, global product registrations, and pharmaceutical compliance activities while contributing to the delivery of critical healthcare solutions worldwide.
Job Description
This Regulatory Affairs Job focuses on managing regulatory submissions, variations, renewals, and compliance activities for European and Rest of World (RoW) markets. The role involves preparing regulatory dossiers, coordinating with health authorities, supporting labeling updates, and ensuring compliance with global pharmaceutical regulations.
The Senior Executive will collaborate with cross-functional teams to maintain regulatory approvals, support product lifecycle management, and ensure uninterrupted product availability across international markets.
Key Responsibilities
- Prepare and submit regulatory applications, variations, and renewals.
- Review dossiers, SmPCs, labeling documents, and regulatory submissions.
- Handle Health Authority queries and prepare RFI response packages.
- Coordinate change controls and regulatory-driven product updates.
- Support artwork and labeling revisions for global markets.
- Maintain regulatory databases, trackers, and document management systems.
- Collaborate with Quality, Supply Chain, Medical Affairs, and Pharmacovigilance teams.
- Monitor regulatory changes and ensure ongoing compliance.
- Develop regulatory submission strategies for assigned products and markets.
- Support SOP preparation and process improvement initiatives.
Eligibility Criteria
- Education: B. Pharm, M. Pharm
- Experience: 3–5 years of Regulatory Affairs experience.
Required Skills
- Regulatory submissions and dossier preparation.
- EU and global pharmaceutical regulations.
- Labeling and artwork compliance.
- Health Authority correspondence and RFI management.
- Regulatory document management systems.
- Microsoft Word and Excel proficiency.
- Strong communication and project coordination skills.
- Attention to detail and a compliance-focused mindset.
Why Apply For This Role?
- Build expertise in global pharmaceutical regulatory affairs.
- Work on EU and international market submissions.
- Gain exposure to global health authority interactions.
- Collaborate with cross-functional pharmaceutical teams.
- Advance your professional growth through a rewarding Piramal Career.
