Opportunity to Work as Regulatory Specialist MSR Coordination at GSK India-Apply before 30th May 2024

GSK India

Website GSK India

About GSK India

GSK, or GlaxoSmithKline, is a leading global pharmaceutical company that focuses on researching, developing, manufacturing, and distributing a wide range of medicines, vaccines, and consumer healthcare products. With a rich history dating back to the 19th century, GSK has established itself as a key player in the healthcare industry, with a presence in over 150 countries.

The company is known for its contributions to areas such as respiratory, HIV, and vaccines, among others. GSK has a strong commitment to innovation and investing in research and development to address unmet medical needs. They also prioritize sustainability and corporate responsibility, aiming to make a positive impact on communities and the environment.

GSK’s mission is to help people do more, feel better, and live longer by providing access to high-quality healthcare products and solutions. They continuously strive to improve global health outcomes and make a meaningful difference in the lives of millions of people worldwide.

Post: Regulatory Specialist MSR Coordination

Job Description:

  • Executes agreed dossier strategy related to MSR packages with minimal input from manager.
  • Liaises with MSR suppliers & customers (GMS, External Supply QA, LOCs) for timely documentation acquisition.
  • Manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals, and regional projects simultaneously, with minimal input from manager.
  • Completes data assessment independently to ensure MSR package suitability and identifies associated risks.
  • Communicates with line manager to address business impact issues, reviews peer work, and identifies Regulatory process improvement opportunities.
  • Develops understanding of regulations, guidelines, procedures, and policies related to pharmaceutical and vaccine product registration and manufacturing.
  • Actively builds an organizational network and communicates across GSK regarding projects and new MSR deliverables requirements with minimal manager input.

Candidate Profile:

  • Bachelor’s degree in biological or healthcare science qualification or Regulatory Affairs experience in Drug development environment.
  • 2-6 years of relevant experience.
  • Proactively manages workload, timelines, and priorities, building relationships with internal functions.
  • Ability to work on multiple projects simultaneously.
  • Broad understanding of pharmaceutical industry, drug development environment, and R&D processes.
  • Global/EMAP Regulatory submission experience and knowledge of regulatory agency guidelines.
  • Excellent organizational skills, attention to detail, and commitment to high-quality output even under regulatory deadlines.
  • Excellent written and verbal communication skills, presenting information clearly and concisely.
  • Ability to interpret and advise on global guidelines and requirements based on recent GSK experience.
  • Ability to build effective working relationships and thrive in a matrix environment.
  • Flexible thinking to meet shifting priorities and timelines.

Additional Information:

  • Experience: 2-6 years
  • Qualification: M.Sc/B.Pharm/M.Pharm
  • Location: Bengaluru Luxor North Tower
  • Industry Type: Pharma/Healthcare/Clinical research
  • Functional Area: Regulatory Specialist
  • Req ID: 395988
  • End Date: 30th May 2024
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To apply for this job please visit jobs.gsk.com.