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GlaxoSmithKline Pharmaceuticals

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4.1

based on 1.8k Reviews

Video summary

52 GlaxoSmithKline Pharmaceuticals Jobs

Regulatory Associate Manager - Global Labelling

GlaxoSmithKline Pharmaceuticals Limited

4.1

based on 1.8k Reviews

4-7 years

Bangalore / Bengaluru

1 vacancy

Regulatory Associate Manager - Global Labelling

GlaxoSmithKline Pharmaceuticals

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

HRIS Pharmacy Regulatory Affairs Recruitment Procurement Internal Audit

+ 2 more

Job Description

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