Gland Pharma Job vacancy for Deputy Manager / Manager – Drug Regulatory Affairs (DRA) – Submit Resume

Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. We operate primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectables. 

Gland Pharma Job vacancy

• Department: Drug Regulatory Affairs (DRA)
• Experience : 8 to 13 Years
• Education- M. Pharmacy
• Designation: Deputy Manager / Manager
• Openings: 5

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Email ID : Eswarreddy.ravi@glandpharma.com

Job description

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 Labeling : 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.

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