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  • Regulatory Affairs Professionals in following roles are preferred: New Submissions - Submission of dossiers to Global Health Authorities (esp. US, EU, CANADA & ANZ). Experience in Parenteral Dosage forms is preferable. Life-Cycle Management - Submission of post-approval changes

  • New Submissions - Submission of dossiers to Global Health Authorities (esp. US, EU, CANADA & ANZ). Experience in Parenteral Dosage forms is preferable. Life-Cycle Management - Submission of post-approval changes (Supplements/Variations) to Global Health Authorities (esp. US, EU, CANADA & ANZ ...

  • Position will be responsible for 1. Review and finalizing of regulatory strategy related to product filing (White paper/Controlled correspondence/Filling pathways/Query response), Change control, Deviations and other R&D/Plant documents* for Regulatory Submission or cGMP Compliance throughout

  • Position will be responsible for 1. Review and finalizing of regulatory strategy related to product filing (White paper/Controlled correspondence/Filling pathways/Query response), Change control, Deviations and other R&D/Plant documents* for Regulatory Submission or cGMP Compliance throughout

  • Position will be responsible for 1. Review and finalizing of regulatory strategy related to product filing (White paper/Controlled correspondence/Filling pathways/Query response), Change control, Deviations and other R&D/Plant documents* for Regulatory Submission or cGMP Compliance throughout

  • concerning news or updates related to electronic publishing of submissions. Monitor regulatory affairs trends that are related to environmental issues. Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes Qualification: Bachelor Degree in a scientific discipline. Experience: 10 - 15 years experience in Regulatory Affairs from a Pharma industry ...

  • concerning news or updates related to electronic publishing of submissions. Monitor regulatory affairs trends that are related to environmental issues. Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes Qualification: Bachelor Degree in a scientific discipline. Experience: 10 - 15 years experience in Regulatory Affairs from a Pharma industry ...

  • concerning news or updates related to electronic publishing of submissions. Monitor regulatory affairs trends that are related to environmental issues. Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes Qualification: Bachelor Degree in a scientific discipline. Experience: 10 - 15 years experience in Regulatory Affairs from a Pharma industry ...

  • concerning news or updates related to electronic publishing of submissions. Monitor regulatory affairs trends that are related to environmental issues. Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes Qualification: Bachelor Degree in a scientific discipline. Experience: 10 - 15 years experience in Regulatory Affairs from a Pharma industry ...

  • Qualification: B.Pharm / MPharm. Exp: 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 ...

  • Qualification: B.Pharm / MPharm. Exp: 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 ...

  • Qualification: B.Pharm / MPharm. Exp: 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 ...

  • Qualification: B.Pharm / MPharm. Exp: 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 ...

  • Qualification: B.Pharm / MPharm. Exp: 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 ...

  • Communications with Business Division for New Product Development Projects. * Proactively assess policies and emerging issues related to Medical Devices and work closely with divisions to develop and implement strategies to address the impact from regulatory perspective * Work with other divisional regulatory Skill Set Primary * Working experience of Regulatory submissions in medical Device Industry such ...

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

  • of International is a plus * Regulatory affairs experience in the Medical Device industry or related industry is required. Personality: * Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. * Ability to manage priorities / workflow of multiple projects while

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