Regulatory Associate Manager – Global Labelling

•  Bengaluru, India
•  Regulatory
•  417299

Job description

Site Name: Bengaluru Luxor North Tower
Posted Date: Mar 10 2025

Key Responsibilities –

• Maintain the Global Datasheet (GDS) in conjunction with functional experts.
• Maintain the EU PI (CP/MRP/DCP), International Product Information (IPI), Vx WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling difference if any.
• Manage the PI for products in conjunction with a third party.
• Coordinate the readability testing of the EU Package Leaflet when applicable.
• Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the GDS and centrally managed PIs (when applicable) and seek agreement with all stakeholders involved.
• Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC). Author GLC meeting minutes (if applicable).
• Support the Local Operating Companies (LOC):
  • in the implementation of Global PI text into country PI.
  • in authoring and coordinating responses to labelling questions from regulatory agencies.
  • in evaluating LOC submission delay request and facilitating its approval if required.
• Demonstrate expertise in GSK Global Labelling processes.
• Effectively plan, prioritize, communicate and deliver quality labelling documents according to timelines and submission requirements.
• Participate in other projects and activities, implement the changes to labelling processes, new regulations and guidelines. Proactively identify the areas for improvements/efficiencies in existing labelling processes.
• Take accountability for relevant sections of the periodic aggregate reports like PBRER, ACO, Addendum Reports, DSUR, etc.
• Member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT) as appropriate.
• May represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
• Train/coach others, as required.
• May represent GSK Global Labelling in
  • inspections or meetings with regulatory authorities.
  • external events (conferences/ seminars, etc.).

Minimum experience –

• >7 years relevant experience (in pharmaceutical industry or regulatory).
• Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
• Preferred experience in labelling or regulatory affairs

Education requirements –

Bachelors / master’s degree in Life Sciences or Pharmacology or equivalent

Other Job-Related Skills –

• Excellent English written and verbal communication skills.
• Clearly express key messages, both written and orally and ability to present information in a clear and concise manner.
• Attention to detail, excellent organization and time management skills, ability to multitask.
• Demonstrate an understanding of priorities and think flexibly in order to meet constantly shifting priorities and timelines and to independently propose solutions to issues.
• Resolve most problems independently, using sound decision making processes and communicates decisions and rationale effectively.
• Show a focus on improving performance and excellence in all tasks.
• Ability to recognize and resolve conflict and arbitrate as necessary.
• Team Spirit: Work well in team setting.
• Building network
• Patient focused