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
Email ID : [email protected]
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.
