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Freshers Pharma Jobs GSK – Apply For Regulatory Specialist

Regulatory Specialist – Submissions Assembly

Bengaluru, India



Site Name: Bengaluru Luxor North Tower

Posted Date: Nov 28 2023

Job Purpose:

The Regulatory Submission Assembly – Level 1 role is to co-ordinate between multiple stakeholders/LOC, to obtain regulatory submission documents for preparation of quality dossier in agreed timeline and submissions to respective agencies with high quality.

Key Responsibilities:

  • Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines.
  • Delivery of submission packages to agreed schedule and technical specification
  • Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures
  • Works across the functions and can work with Stakeholders in development functions in provision of advice interpretation of relevant guidance’s, researching topics and resolving issues.
  • Understanding of regulations, guidelines and developing procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.

Job-Related Experience:

  • 0-6 years of experience in Regulatory Affairs or related responsibilities.
  • Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
  • Ability to build effective working relationships and work in a matrix environment effectively.
  • Excellent computer knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer etc.) and preferably experience with the use of complex IT tools in a large organization.
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Other Job-Related Skills/Background:

  • Can communicate effectively in English.
  • Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.
  • Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
  • Highly developed interpersonal, presentation and communication skills with established internal and external networks.
  • Ability to work carefully/independently under time constraints.


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