AmbitionBox
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
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
Read full job descriptionPrepare for Regulatory Associate roles with real interview advice
What people at GlaxoSmithKline Pharmaceuticals are saying
Rating based on 1 Regulatory Associate
review
Anonymous · Research & Development
in Hyderabad / Secunderabad
Work life balance Career Development
- Salary - Good
Salary structure Hikes Promotions
Regulatory Associate salary at GlaxoSmithKline Pharmaceuticals
Unlock 
What GlaxoSmithKline Pharmaceuticals employees are saying about work life
GlaxoSmithKline Pharmaceuticals Benefits
View more benefits
Compare GlaxoSmithKline Pharmaceuticals with
Sun Pharmaceutical Industries
Cipla
DRJ & CO
Biocon Limited
Zydus Lifesciences
Aurobindo Pharma
Lupin
Torrent Pharmaceuticals
Glenmark Pharmaceuticals
DIVI'S Laboratories
Hetero
Abbott
Micro Labs
Pfizer
Biological E
Granules India
Gland Pharma
Sanofi
Unichem Laboratories
Fresenius Kabi
Associate Director - Commercial Excellence & Analytics
8-12 Yrs
Bangalore / Bengaluru
Associate Director - Product Owner - Veeva Vault CRM
16-20 Yrs
Bangalore / Bengaluru
Procurement Delivery Centre Operation Sr. Manager-2
10-15 Yrs
Bangalore / Bengaluru
Senior Principal Engineer Commercial Tech Access
16-18 Yrs
Bangalore / Bengaluru
Recently Viewed
SALARIES
suzuki motor gujarat
REVIEWS
suzuki motor gujarat
No Reviews
REVIEWS
GlaxoSmithKline Pharmaceuticals
No Reviews
REVIEWS
GlaxoSmithKline Pharmaceuticals
No Reviews
REVIEWS
GlaxoSmithKline Pharmaceuticals
No Reviews
REVIEWS
GlaxoSmithKline Pharmaceuticals
No Reviews
SALARIES
suzuki motor gujarat
REVIEWS
GlaxoSmithKline Pharmaceuticals
No Reviews
