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49 GlaxoSmithKline Pharmaceuticals Jobs
Regulatory Associate Manager - Global Labelling
4-7 years
Bangalore / Bengaluru
1 vacancy
Regulatory Associate Manager - Global Labelling
GlaxoSmithKline Pharmaceuticals
posted 2d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.).
- >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
- 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
Important notice to Employment businesses/ Agencies
Employment Type: Full Time, Permanent
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Anonymous · Research & Development
in Hyderabad / Secunderabad
Work life balance Career Development
- Salary - Good
Salary structure Hikes Promotions
Regulatory Associate salary at GlaxoSmithKline Pharmaceuticals
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