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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Operations Management / Process AnalysisSales / BD |
| EmploymentType | Full-time |
You will be based at corporate office at Mumbai.Job Description shall be as follows : 1) Experience in handling regulatory affairs for regulated markets in EU markets preferred(US+UK both markets will do but EU markets experience preferred) 2) Candidate from pharma company only. 3) To formulate regulatory strategy & lead roadmap for eCTD dossier filing and getting MAs in regulated markets. Providing assessments, opinion, analysis, pathways, Identification of target country for selected molecule. Exposure to EU-GMP / US FDA audit. 4) To perform functions like Regulatory compliance with thorough knowledge of all the modules, e-CTD filing, planning, meet project timelines, Training, Risk management & act as Team leader. 5) To ensure compliance of products with the current regulations, monitoring of international legislation, guidelines and customer practices, planning and communicating with external agencies. 6) To anticipate regulatory obstacles for trouble-shooting in new product development activities and emerging issues throughout the product life cycle. 7) To handle post-approval variations & facilitate smooth approvals for uninterrupted supplies. 8) To manage and develop the team below him. 9) The candidate will be of such a calibre that he will be required to handle a team size of 2 3 people to start with. Required Candidate profileCandidate with B. Pharma, M. Pharma, Masters in science(like organic chemistry)-You should have experience in handling regulatory affairs for regulated markets in EU markets preferred (US+UK both markets will do but EU markets experience preferred).-Candidate will be of such a calibre that he will be required to handle a team size of 2 3 people,
Keyskills :
management pharma planning filing analysis strategy training ewproductdevelopment productdevelopment riskmanagement regulatorycompliance legislativerelations