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13 jobs found for Pharma Regulatory Affairs Mumbai Manager

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  • 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 ...

  • 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

  • Obtaining approval of shareholders on all proposals at the Annual General Meeting. Updating of websites Close on all Action items arising out of Board and committee meetings and systematic reporting of the same. Liasioning with various Regulatory authorities / external agencies on behalf Have Past Working Experience in Similar roles. Able to Handle all compliance work ...

  • 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

  • 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: B Pharm/ M Pharm. 6-8 years experience Should have hands on experience for regulatory requirements relevant to Topical products (Ointments, Creams, Gels). Should have hands on experience for ANDA preparations & submissions ...

  • Qualification: Masters in Microbiology. 6-8 years experience Should have hands on exp. for regulatory requirements relevant to Injectables. Sound knowledge of requirements of Microbiological validations / Aseptic/Sterilization processes & validations

  • Qualification: B Pharm/M Pharma. 4-8 years experience. Should have hands on experience for ANDA preparations & submissions. Knowledge of ICH / FDA Guidance documents. OCR, Book marking, hyperlinking, QC check. Coordinating and collating the documents relevant to ANDA compilation from different functions. Review of documents for adequacy (wrt content, requirements, legibility, PDF requirements, et ...

  • Qualification: MPharm. Experience: 10-12 years. Should have hands on experience for end to end ANDA preparations & submissions. - Sound knowledge of current regulatory expectations wrt GDUFA II. Sound knowledge of ICH / FDA Guidance documents ...

  • of customer and International regulatory audits, statutory compliance like FDA related matters.). Timely responses to customer queries/audit reports and ensure CAPA implementation. Monitor and control over departmental revenue expenses. GMP trainings to subordinates. Should have direct exposure for various Candidate should be B.Pharm or M.Pharm. Should have adequate exposure in both API & FDF integrated ...

  • to professionally develop and coach team members Solid understanding of healthcare/medical industry and regulatory requirements Ability to build positive working relationships, both internally and externally. Excellent oral and written communication skills Good working knowledge of Microsoft Office Preferred ...

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