Regulatory Specialist 1 Product Variations

4 weeks ago

Bengaluru, Karnataka, India GSK Full time
Nazwa biura: Bengaluru Luxor North Tower
Posted Date: Apr

Job Purpose :

  • Provides timely support for regulatory delivery activities of assigned Rx and/or Vx CMC projects with management input.

Supports Global Regulatory by producing appropriate components for global regulatory dossiers with appropriate guidance from supervisor, as necessary.

Key Responsibilities :

  • Developing an understanding of regulations, guidelines, procedures and policies. relating to registration and manufacturing of pharmaceutical products.
  • With management oversight, ensuring data and information packages are fit for purpose.
  • Beginning to understand internal/external CMC Regulatory environment.
  • Begin to build organisational networks.
  • Regular communication with line manager to help identify any CMC issues with business impact.

Conducts routine Rx and/or Vx CMC projects with support.

Job-Related Experience

3-6years of relevant experience.

Naszym celem jest być jedną z najbardziej innowacyjnych, najlepiej działających i zaufanych firm z branży opieki zdrowotnej na świecie. Wierzymy, że wszyscy wnosimy coś wyjątkowego do GSK i kiedy łączymy naszą wiedzę, doświadczenia i styl, wpływ, jaki mamy na świat jest niesamowity. Dołącz do naszej przygody w GSK, gdzie zainspirujemy Cię do wykonywania najlepszej pracy dla naszych pacjentów i klientów. Miejsce, w którym możesz być sobą, czuć się dobrze i się rozwijać.

Ważna informacja dla biur/agencji pośrednictwa pracy

GSK nie akceptuje poleceń pracowników od biur i/lub agencji pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie. Wszystkie biura/agencje pośrednictwa pracy są zobowiązane do skontaktowania się z działem handlowym i ogólnym/kadr GSK w celu uzyskania wcześniejszej pisemnej zgody przed poleceniem kandydatów firmie GSK. Uzyskanie uprzedniej pisemnej zgody jest nadrzędne w stosunku do jakiejkolwiek umowy (ustnej lub pisemnej) między biurem/agencją pośrednictwa pracy a GSK. W przypadku braku takowego pisemnego upoważnienia wszelkie działania podejmowane przez biuro/agencję pośrednictwa pracy będą uważane za wykonane bez zgody lub umownego porozumienia ze strony GSK. GSK nie ponosi zatem odpowiedzialności za jakiekolwiek opłaty wynikające z takich działań lub wynikające z polecenia danej osoby przez biura/agencje pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie.

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