Regulatory Affairs Consultant

3 weeks ago

Bengaluru, Karnataka, India Parexel Full time

Regulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) 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, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.Responsible for managing (Authoring and Review) of biologics/biosimilar/vaccine investigational product submission such as IND & IMPD for USFDA, EMAAuthoring, review, and submission of BLA/MAA dossiers for US/EU/ROW /India markets.Preparation of regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA applications.Life cycle management (LCM) for approved products. (annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN)Evaluation of change controls and deviations and defining regulatory strategyPreparation and submission of scientific advice, briefing book, Type 2 meeting packages for USFDA and EMACo-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible.Develop up-to-date knowledge about regulatory guidelines and applies regulatory requirements and their impact on submissions.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.

  • Regulatory Affairs Consultant

    2 weeks ago

    Bengaluru, Karnataka, India Parexel Full time

    Regulatory 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...

  • Regulatory Affairs Consultant

    8 hours ago

    Bengaluru, Karnataka, India Parexel Full time

    8+ 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nome 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    İş 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nome 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nazwa 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nombre 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Standort: 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nama 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nom 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Tên 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Pobočka: 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nom 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Locație: 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Site 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    근무지: 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...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Munkavégzés 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...

  • 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...

  • 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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    Bengaluru, Karnataka, India iimjobs Full time

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