Gland Pharma is the worlds leading player in Injectables Formulation and Manufacturing. It is also into API and Intermediates research and manufacturing. Gland Pharma is present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505b2 filings.
Hiring experienced Drug Regulatory Affairs (DRA) professionals.
Post : Assistant Manager / Deputy Manager
Role & Responsibilities :
1. For CMC : Regulatory Markets
• Compilation of regulatory dossiers meeting various regulated market requirement for US, EU and Canada etc.
• Coordination with various departments like QC, QA, R&D, Production, Warehouse and Packaging for required documents in connection to compilation of dossiers.
• Draft preparation of text matter for artworks/labels. Review of artworks and updating for all regulatory submissions.
• Responsible for compilation & submission of ANDAs in eCTD format and SPL Publication to USFDA.
• Responsible for preparation and submission of PAS, CBE supplements and Annual reports for approved products of USFDA.
• Review of the documents such as stability protocol & reports, process validation, art works, specifications and test methods which are part of regulatory submission.
• Review of Raw Material/Finished product specifications, STPs, CoAs Analytical/Process method validations, PDRs, Annual product reviews, stability specifications, protocols, stability data and all regulatory documents.
• Life cycle management of Approved Dossiers.
2. For Labelling : US Market
• Responsible for preparation and submission of CBE supplements for approved products to US FDA.
• Responsible for eCTD Submission, Publication, and product life-cycle management.
• Responsible for allotting NDC numbers.
• Reporting of ADER and FAR to USFDA.
• Review of BPCRs Raw Material/Finished product Specification, STPs, CoAs, Annual Product Review, Stability specification, stability protocols, and all regulatory documents.
• Draft preparation of text matter for artworks/Labels. Review and Approval of Artworks, change controls and updating for all Regulatory Submissions.
• Initiation of Change Controls regarding Artworks.
• Coordination with various departments like QC, QA, R&D, Production, Warehouse and Packaging for required documents in connection with preparation of artworks.
• Compilation of eCTD modules and SPL Publication to USFDA.
• Filed product dossier life cycle maintenance.
• Approval of artworks in software.
• Annual establishment registration and BNCC certification.
• Approval of print proofs.
• Preparation of SOPs related to Drug Regulatory Affairs.
• Preparation, review and submission of customer import listing SPLs.
Additional Information
Qualification : M.Pharmacy
Work Location : Dundigal / Pashamylaram
Experience : 8 - 12 Years
End Date : 15th December, 2023
Please share CV to eswarreddy.ravi@glandpharma.com
Mention subject as "Drug Regulatory Affairs AM/DM"
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