MACLEODS PHARMACEUTICALS LTD. - URGENTLY OPENING FOR REGULATORY AFFAIRS ( MANAGER ) | APPLY ONLINE
Job Opening :- Regulatory Affairs ( Manager )
Experienced Required :- 10 - 14 yrs
Qualification :- B.Pharm, M.Pharm
Job Location :- Mumbai
Job Description
Preparation, review, compilation and submission of the ANDA application as per the current prescribed guidelines of the regulatory authorities.
Preparation review, compilation and submission of document for ANDA amendments (Major, minor), Supplements (CBE, CBE-30 and PAS) and Annual Reports to Approved ANDA
Preparation and review of SPL, package insert and labeling information.
Prepare responses to health authorities various queries during registration / renewal.
Prepared & submitted application for Post Approval Changes.
Review of technical documents required for filing such as Drug Master File, Product Development Report, Batch Manufacturing Record, Batch Packaging Record, Analytical Method Validation / verification reports, Process validation, Stability study, Specification / Standard Testing
Procedure, Certificate of analysis, Master Manufacturing Documents etc.
Co-ordination with various departments such as QA, QC, Purchase, Exports, R&D, Production, Packaging, and ADL for technical documents such as process validation, analytical method validation, and stability study data, API, Raw material, finished product COAs & specification about all the
documents related to product registration.
Proficiency in communication with various countries for timely and smooth registration.
Maintenance of database for life cycle of the product viz. status of filings, approval details, approved
variations, renewal, compliance of post approval commitments etc.
Company Profile: Macleods Pharmaceuticals Ltd.
Macleods, Indiaà ¢ €⠄¢ s fastest growing pharmaceutical company, with a strong R&D and own bio-equivalence center, manufacturing sites approved by USFDA & WHO Geneva, ranked among the top pharmaceutical companies with a strength of more than 10,000 employees , presently operating in more than 50 countries worldwide.
Experienced Required :- 10 - 14 yrs
Qualification :- B.Pharm, M.Pharm
Job Location :- Mumbai
Job Description
Preparation, review, compilation and submission of the ANDA application as per the current prescribed guidelines of the regulatory authorities.
Preparation review, compilation and submission of document for ANDA amendments (Major, minor), Supplements (CBE, CBE-30 and PAS) and Annual Reports to Approved ANDA
Preparation and review of SPL, package insert and labeling information.
Prepare responses to health authorities various queries during registration / renewal.
Prepared & submitted application for Post Approval Changes.
Review of technical documents required for filing such as Drug Master File, Product Development Report, Batch Manufacturing Record, Batch Packaging Record, Analytical Method Validation / verification reports, Process validation, Stability study, Specification / Standard Testing
Procedure, Certificate of analysis, Master Manufacturing Documents etc.
Co-ordination with various departments such as QA, QC, Purchase, Exports, R&D, Production, Packaging, and ADL for technical documents such as process validation, analytical method validation, and stability study data, API, Raw material, finished product COAs & specification about all the
documents related to product registration.
Proficiency in communication with various countries for timely and smooth registration.
Maintenance of database for life cycle of the product viz. status of filings, approval details, approved
variations, renewal, compliance of post approval commitments etc.
Company Profile: Macleods Pharmaceuticals Ltd.
Macleods, Indiaà ¢ €⠄¢ s fastest growing pharmaceutical company, with a strong R&D and own bio-equivalence center, manufacturing sites approved by USFDA & WHO Geneva, ranked among the top pharmaceutical companies with a strength of more than 10,000 employees , presently operating in more than 50 countries worldwide.
Tags:
Regulatory Affairs