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  • Thorough knowledge of QMS/ ISO 13485 / Regulatory affairs Thorough knowledge of QMS/ ISO 13485 a regulatory subject matter expert through cross functional collaboration with R&D and relevant stakeholders to ensure regulatory compliance healthcare ind

  • 1. Executive / Officer - Regulatory 2. Location: Dehradun and Mumbai 3) Experience: 3years to 10years 4) Education: M Pharm/ B Pharm 5) Gender: Male / Female 6) J D : should have knowledge of Regulatory Affairs ,preparing Dossiers for ROW markets, documentation and co ordination ...

  • To review ANDA and file electronically through FDA gateway. Pre-approval Submission in original ANDA filing, getting the AFFL letter with no RTR and DL responses in time. - Filing, Pre-approval & post approval maintenance of ANDAs - Exposure to working for Regulated Markets in Regulatory Affairs

  • and existing product improvements from regulatory perspectives. Art work review, license review and approval of drug products. FDA and CDSCO Notices replies for not of standard quality complaints. Follow up for the resolution of the NSQ complaints. Coordination with the medical department for drafting

  • and existing product improvements from regulatory perspectives. Art work review, license review and approval of drug products. FDA and CDSCO Notices replies for not of standard quality complaints. Follow up for the resolution of the NSQ complaints. Coordination with the medical department for drafting

  • Sr. Level: Dept. - Cardiology (Doctor) Desirable Qualification: MBBS, MS, 1-3 years post qualification experience in Medical Affairs / Medico Marketing (Cardio) 2. Jr. Level: Dept. - Cardiology Desirable Qualification : BAMS, BHMS or M.Pharma (Pharmacology), 1-3 years post qualification

  • Preparing medical presentation, monographs, launch presentation for new launch. Post launch marketing support if required. Interaction with KOLs. Work with Senior Medical Advisor to develop the KOL and stakeholder engagement plans in accordance with overall strategic brand plan. Contribute to the development of the medical component of the Brand Strategy and develop a medical plan for each assigned ...

  • to DRA-ROW. -Training of DRA personnel w.r.t understanding of Regulatory guidelines. -Submission of monthly MIS. -Responsible for handling of DRA sample Store. -Responsible for submission to Pharmexcil for fees reimbursement. Personality Traits - Flexible, go getter attitude Hardworking, sincere

  • -Timely dispatches of queries (within 15days from the day of receipt) -Co-ordination with Marketing / Commercial/ PPIC / other departments within Advent for matters related to DRA-ROW. -Training of DRA personnel w.r.t understanding of Regulatory guidelines. -Submission of monthly MIS. -Responsible

  • Preparing medical presentation, monographs, launch presentation for new launch. Post launch marketing support if required. Interaction with KOLs. Work with Senior Medical Advisor to develop the KOL and stakeholder engagement plans in accordance with overall strategic brand plan. Contribute to the development of the medical component of the Brand Strategy and develop a medical plan for each assigned ...

  • 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 ...

  • 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 ...

  • Affairs, 45% for Pharmacovigilance and 45% for Quality Assurance, the work allocation may change as per the requirement of the company. Candidates having good experience in Quality Assurance,RA in pharmaceutical industry. Prefer will be Ophthalmology exp ...

  • Exp in Pharma/ Biotech project incl Sterile, Non-sterile, high Potent Drugs formulation facilities. Project mgmt skill. Should have handled Pharma / Biotech proj as team leader. Regulatory knowledge FAD BMP MHRA WHO BMP, engg designs & parameters Should be able at read and interpret technical drawings, and provide improvement suggestions. Should be able to handle project for Pharma plant new set up and ...

  • groups within Safety and other business units, such as Regulatory Affairs, Clinical Research, Quality, and Information Technology, as needed. 5. Participate in internal and external audits, as required. 6. Conduct ongoing literature safety surveillance for marketed and investigational products

  • groups within Safety and other business units, such as Regulatory Affairs, Clinical Research, Quality, and Information Technology, as needed. 5. Participate in internal and external audits, as required. 6. Conduct ongoing literature safety surveillance for marketed and investigational products

  • relevant sales and market personnel. To comply with all corporate governance requirements and regulatory requirements. Work with the Clinical Affairs Team with KOL meetings/ presentations. Assist in the training of new Territory Sales Managers. Collaborate on marketing programmes by monitoring

  • of Chemicals. FDA Approved candidates. Desired Candidates : Professionals with Positive Attitude Leadership qualities Clear and Focus approach towards Business Objectives Kindly Note : Pharma Professionals having above Qualities and Experience ONLY apply

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