Piramal Pharma Ltd
Website:
piramalpharma.com
Job details:
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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Manager - Regulatory Affairs
Job Description
Piramal Pharma Limited is seeking a highly motivated and experienced Manager, Regulatory Affairs to lead and manage regulatory submissions and compliance activities across various markets. This role ensures timely approval of products and maintains regulatory adherence throughout the product lifecycle.
- Compile, review, and submit regulatory dossiers and submissions, including eCTD format, for the US, Europe, and other regulated markets.
- Manage DMFs, including preparation, review, updates, and lifecycle management.
- Maintain and manage regulatory databases for new submissions, lifecycle changes, regulatory responses, LOAs, Applicant Parts, and Restricted Parts.
- Plan, schedule, and submit annual reports, amendments, and variations as per regulatory timelines.
- Prepare, review, and submit responses to queries received from regulatory authorities and customers.
- Coordinate with Business Development, QA, QC, Production, and R&D to meet customer requirements and regulatory compliance.
- Review and approve change controls, deviations, and required QMS documentation.
- Issue NDCs and ensure timely updates to internal regulatory databases.
- Liaise with local FDA, CDSCO, and other regulatory agencies for approvals of mandatory licenses and regulatory requirements.
- Support and execute day-to-day Regulatory Affairs activities as per organizational needs
Master of Science (MSc)Quality Management System (QMS) Compliance, Quality Management Systems (QMS)
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