Regulatory Associate Manager

2 weeks ago

Bengaluru, Karnataka, India GSK Full time
Tên địa điểm: Bengaluru Luxor North Tower
Ngày 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 Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.
  • Will serve as a mentor/trainer for new team members.

May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department.

Key Responsibilities :

  • Independently and confidently executes agreed dossier strategy.
  • Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
  • Independently completes data assessment to ensure dossier is fit for purpose.
  • Identifies risks associated with submission data and information packages.
  • Escalates issues with line manager that have business impact.
  • May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
  • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
  • Understands internal/external Regulatory environment.
  • Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
  • Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Job-Related Experience

  • Minimum 6-10 years of experience
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Mục tiêu của chúng tôi là trở thành một trong những công ty chăm sóc sức khỏe tiên tiến, hoạt động hiệu quả và đáng tin cậy nhất thế giới. Chúng tôi tin rằng tất cả chúng tôi đều mang lại điều gì đó riêng biệt cho GSK và khi chúng tôi kết hợp kiến thức, kinh nghiệm và phong cách của mình với nhau, thì phạm vi tác động mà chúng tôi đem lại là vô cùng to lớn. Hãy cùng chúng tôi tham gia vào hành trình tại GSK, nơi bạn sẽ được truyền cảm hứng để cống hiến hết sức mình cho bệnh nhân và người tiêu dùng. Một nơi mà bạn có thể là chính mình, cảm thấy thoải mái và không ngừng phát triển.

Thông báo quan trọng dành cho các cơ quan/doanh nghiệp tuyển dụng

GSK không chấp nhận các trường hợp giới thiệu từ các doanh nghiệp và/hoặc cơ quan tuyển dụng liên quan đến tin tuyển dụng đăng trên trang web này. Tất cả các doanh nghiệp/cơ quan tuyển dụng phải liên hệ với phòng nhân sự/đấu thầu chung và thương mại của GSK để nhận được sự đồng ý trước bằng văn bản trước khi giới thiệu bất kỳ ứng viên nào cho GSK. Nhận được sự đồng ý trước bằng văn bản là một điều kiện tiên quyết để đạt được mọi thỏa thuận (bằng lời nói hoặc văn bản) giữa doanh nghiệp/cơ quan tuyển dụng và GSK. Khi không có sự đồng ý trước bằng văn bản, thì bất kỳ hành động nào của doanh nghiệp/cơ quan tuyển dụng sẽ được coi là đã được thực hiện mà chưa được sự cho phép hoặc thỏa thuận bằng hợp đồng của GSK. Do đó, GSK sẽ không chịu trách nhiệm đối với mọi khoản phí phát sinh từ những hành động như vậy hoặc mọi khoản phí phát sinh từ bất kỳ trường hợp giới thiệu nào từ doanh nghiệp/cơ quan tuyển dụng liên quan đến tin tuyển dụng đăng trên trang web này.

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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...

  • Regulatory Reporting Assurance

    1 month ago

    Bengaluru, Karnataka, India State Street Full time

    The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review (CCAR), and areas of...

  • Regulatory Reporting Assurance

    1 month ago

    Bengaluru, Karnataka, India State Street Full time

    The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review (CCAR), and areas of...

  • Regulatory Reporting Assurance

    6 days ago

    Bengaluru, Karnataka, India State Street Full time

    The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review (CCAR), and areas of...

  • Regulatory Reporting Assurance

    3 weeks ago

    Bengaluru, Karnataka, India State Street Full time

    The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Liquidity Reporting, Basel, Comprehensive Capital Analysis and Review...