Job title: Manager- Regulatory Affairs
Company: Naman Staffing
Job description: Job Details Position: Manager- Regulatory Affair Job Location: Multiple Opening for Vadodara & Mumbai Location About the company : One of the leading names in Pharmaceutical Company Job Requirement : Degree in Pharmacy/ Chemistry/ Life science with 5+ Years of Experience in Regulatory Affair from Generic/ Innovator Pharmaceutical Industries. Job Role : Prepare and submit applications of a high standard to regulatory authorities in a timely fashion, working in collaboration with consultants, local partners and distributors where necessary. These include new licence applications, renewals, variations, artwork changes, updates and any other relevant applications or notifications Good knowledge of variation procedures such as types, timings, bundling etc Knowledge of the various regulatory procedures including Centralised procedure, Decentralised Procedure, MRP, national Procedures in UK and within Europe Knowledge of global regulatory requirements including emerging markets Manage International Regulatory Consultants. Evaluation of dossiers received from third parties. Recommendation of appropriate actions needed to ensure expeditious submission and approval. Compilation and submission of Marketing Authorisations and Variation applications. Preparation of responses to regulatory questions in conjunction with third parties. Commission and review artwork for packaging components, in accordance with Departmental and company procedures. Provide advice to colleagues and management on process, status, problems etc. Maintain up to date knowledge of regulatory requirements and advise colleagues and management of implications of new or changing requirements. Contribute to setting up Departmental procedures and policies. Ensure that documentation in relations to own projects is maintained in orderly fashion and can be readily retrieved. Contribute to other Departmental activities, when needed. Management of other Projects Department regulatory affairs staff Strong communication skills with internal and external customers and colleagues Updating of internal documents such as trackers and Gantt charts Experience in CIS, Middle East, EU, ASIA-Pacific markets Preparation of dossiers for MAH transfers, variations, renewals, MAA Contact Person: Sarita Chaudhary Email: sarita@namanstaffing.com Interested candidates can directly APPLY on the below link
Expected salary:
Location: Vadodara, Gujarat
Job date: Wed, 15 Dec 2021 03:28:31 GMT
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