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  • by coordinating with formulation, medical & regulatory departments. 8. Review of published clinical studies, information, Innovator Monographs & implementation in Drug Development process. 9. Consolidate information from multiple sources like studies published in leading medical journals, posted on trial

  • clinical trials in pharma or CRO. In depth SAS programming knowledge. Knowledge and Skills (Functional / Technical) Hands-on experience on multiple CDISC projects (10 or more studies) and Written Reviewers Guide with CDISC package. Working knowledge with SDTM/ADaM/XML Familiarity with statistical methods

  • clinical trials in pharma or CRO. In depth SAS programming knowledge. Knowledge and Skills (Functional / Technical) Hands-on experience on multiple CDISC projects (10 or more studies) and Written Reviewers Guide with CDISC package. Working knowledge with SDTM/ADaM/XML Familiarity with statistical methods

  • customers etc. l Working with Regulatory affairs, Government affairs, Quality, Public affairs and other functions of the company to resolve legal issues. l Assist the businesses with statutory compliance related matters and where necessary, prepare checklists for compliances under relevant laws ...

  • customers etc. l Working with Regulatory affairs, Government affairs, Quality, Public affairs and other functions of the company to resolve legal issues. l Assist the businesses with statutory compliance related matters and where necessary, prepare checklists for compliances under relevant laws ...

  • 1 -3 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • 1 -3 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • Qualification: M.Sc Chemistry with specialization in synthetic organic chemistry. Experience : 6-8 years. Should have hands on experience for DMF preparations & submissions. Knowledge of current regulatory expectations wrt GDUFA II ...

  • Qualification: M.Sc Chemistry with specialization in synthetic organic chemistry. Experience : 6-8 years. Should have hands on experience for DMF preparations & submissions. Knowledge of current regulatory expectations wrt GDUFA II ...

  • Qualification: PhD/ MSc chemistry with specialization with synthetic organic chemistry. Experience: 10-12 years. Should have hands on experience for end to end US DMF submissions (Small molecule, Complex molecule, Sterile API) of GDUFA I period ...

  • Qualification: PhD/ MSc chemistry with specialization with synthetic organic chemistry. Experience: 10-12 years. Should have hands on experience for end to end US DMF submissions (Small molecule, Complex molecule, Sterile API) of GDUFA I period ...

  • 2 -5 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • 2 -5 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • 2 -5 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • 1 -3 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • 1 -3 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines ...

  • Exposure in OOS,OOT investigation,Vendor qualification,vendor Audit,CTD,DMF,Root Cause Analysis,CAPA,Change controls,Market Complaints,Preparation and review of Annual product quality review document,Validation & qualification,regulatory affairs,Aud

  • statutes and General Meetings and to maintain the minutes of these meetings. 3. To advise the Board of Directors on regulatory, procedural and corporate governance related matters. 4. To ensure that affairs of the company are managed in accordance with its objects contained in the Memorandum and Articles

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