{"@context":"https://schema.org","@type":"JobPosting","title":"Manager/Sr. Manager QARA Pharma","description":"

#hiring Manager/ Sr. Manager QARA - Pharma for a reputed organization

Key Responsibilities:

Lead regulatory strategy, submissions, approvals, and compliance activities for pharmaceutical products.
• Drive end-to-end EU GMP approval activities for manufacturing facilities and products.
• Manage regulatory submissions, variations, renewals, responses, and compliance requirements.
• Lead and coordinate regulatory inspections, audits, and agency interactions.
• Provide regulatory support for Sterile Injectables and Ophthalmic (Eye Drop) products.
• Ensure compliance with EU GMP requirements and international regulatory standards.
• Review and approve regulatory dossiers, submissions, and supporting documentation.
• Collaborate with Quality Assurance, Manufacturing, Validation, and Technical Services teams.
• Monitor evolving regulatory requirements and implement compliance strategies

Mandatory Requirements:
• 1520 years of Regulatory Affairs experience.
• Strong experience in Sterile Injectables and Ophthalmic (Eye Drop) products.
• Good understanding of Aseptic Manufacturing requirements.
• Proven hands-on experience in obtaining regulatory approvals and managing EU GMP approvals from end to end.
• Experience in regulatory inspections, audit coordination, compliance management, and post-approval activities.
• Experience should be predominantly in Pharmaceutical Regulatory Affairs

","datePosted":"2026-06-23T00:00:00.000Z","validThrough":"2026-08-22T00:00:00.000Z","employmentType":"FULL_TIME","identifier":{"@type":"PropertyValue","name":"myjobb-ai","value":"4247279"},"url":"https://myjobb.ai/jobs/manager-sr-manager-qara-pharma/4247279","directApply":false,"hiringOrganization":{"@type":"Organization","name":"Apogee Services Pvt. Ltd.","logo":"https://img.naukimg.com/logo_images/groups/v1/4694999.gif","sameAs":"https://www.apogeeservices.com/"},"jobLocation":[{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hyderabad","addressRegion":"Telangana","addressCountry":"India"}}],"baseSalary":{"@type":"MonetaryAmount","currency":"INR","value":{"@type":"QuantitativeValue","minValue":2500000,"maxValue":4000000,"unitText":"YEAR"}}}