Regulatory Associate Manager Job – Global Labelling at GSK, Apply Now!
Are you an experienced regulatory professional looking for a dynamic role in global labelling? GSK is hiring a Regulatory Associate Manager – Global Labelling in Bengaluru, India. This role involves managing global product information, ensuring compliance, and leading regulatory discussions. If you have 7+ years of experience in regulatory affairs or labelling, along with strong communication and organizational skills, this opportunity at GSK could be the perfect fit for you.
Job Posting: Regulatory Associate Manager – Global Labelling
Location: Bengaluru, India
Job ID: 417299
Site Name: Bengaluru Luxor North Tower
Key Responsibilities for Regulatory Associate Manager Job:
- 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 preferred for Regulatory Associate Manager Job.
- 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: More than 7 years of relevant experience in the pharmaceutical industry or regulatory affairs
Education Requirements: Bachelors / master’s degree in Life Sciences or Pharmacology or equivalent
Other Job-Related Skills for Regulatory Associate Manager Job:
- 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
Keywords: Regulatory Associate Manager, Global Labelling, GSK, Regulatory Affairs, Pharmaceutical Industry, Bengaluru
