Senior Regulatory Affairs Associate
3 weeks ago
Senior Regulatory Affairs Associate-Biologics
Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantageExperience in handling CMC related health authority queriesGood understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.Preparation and review of Marketing Authorization Applications & Variations forvarious types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).Preparation of documentation for different types of Variation procedures like Super grouping,Grouping and Work-sharing to the Marketing Authorizations.Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissionsLiaise closely with cross-functional members with aligned product responsibilities.Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.Working experience in Regulatory Information Management Systems like Veeva Vault.Strong communications skills and ability to guide and mentor team members.
Ability to work independently.
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Regulatory Affairs Consultant
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs Consultant.8 years' experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant) and...
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Regulatory Affairs Consultant
8 hours ago
Bengaluru, Karnataka, India Parexel Full time8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNome do Local: Bengaluru Luxor North TowerData da Publicação: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeİş Yeri: Bengaluru Luxor North TowerYayın tarihi: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNome della sede: Bengaluru Luxor North TowerData di apertura: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNazwa biura: Bengaluru Luxor North TowerPosted Date: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNombre del sítio: Bengaluru Luxor North TowerFecha de publicación: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeStandort: Bengaluru Luxor North TowerDatum: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNama Site: Bengaluru Luxor North TowerTanggal Posting: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNom du site: Bengaluru Luxor North TowerData de publication: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeTên địa điểm: Bengaluru Luxor North TowerNgày đăng tuyển: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timePobočka: Bengaluru Luxor North TowerDatum zveřejnění: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeNom du site: Bengaluru Luxor North TowerDate de publication: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeLocație: Bengaluru Luxor North TowerData postării: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeSite Name: Bengaluru Luxor North TowerPosted Date: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full time근무지: Bengaluru Luxor North Tower포스팅 날짜: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full timeMunkavégzés helye: Bengaluru Luxor North TowerKihirdetett időpont: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full time工作地點名稱: Bengaluru Luxor North Tower刊登日期: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...
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Regulatory Associate Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full time勤務地: Bengaluru Luxor North Tower公開日: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations...
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Associate Director
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