Sreesapna M
Bangalore
Summary
Dynamic Country Labeling Manager at GSK with a proven track record in regulatory compliance and project management. Expert in leading cross-functional teams to streamline labeling processes, ensuring timely submissions across 100+ markets. Adept at stakeholder communication and staff development, driving efficiency and quality in labeling documentation.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Country Labeling Manager
GSK
Bangalore
10.2021 - Current
- Managed functional labelling operations across Cairo, Poland, Mexico, and India, delivering compliant packages for 100+ markets.
- Recruited and led a skilled team to maintain knowledge necessary for effective workload management.
- Supported Pharma and Vaccine labeling processes, ensuring adherence to GSK and external requirements.
- Compiled and authored Regional/Country PI as per regulatory authority guidelines and GSK standards.
- Developed market-specific documentation for labeling submissions in line with regulations.
- Performed quality checks on content of labeling documents to ensure compliance.
- Streamlined labeling documentation processes within regulatory systems for improved efficiency.
- Collaborated with GSK teams to author quality labeling documents while addressing regulatory queries.
Regulatory Specialist - Labelling Coordinator
GSK
Bangalore
10.2018 - 10.2021
- Supported GRA-labelling processes and systems in alignment with GSK policies and procedures.
- Authored and compiled Regional/Country PI and market-specific documentation for labelling submissions.
- Managed GRA Labelling data in regulatory systems, including VEEVA, PRION, IMMS, and OPAL.
- Assigned requests to peer authors while resolving issues through coordination with relevant teams.
- Performed quality checks on labelling documents drafted by peer authors to ensure consistency.
- Coordinated communication of labelling documentation, such as Global Product Information and EU PI.
- Participated in projects to implement changes within GRA Labelling processes as needed.
- Trained new joiners on labelling processes and guided team members during onboarding.
Labeling Manager
INDEGENE LIFESYSTEMS PVT. LTD.
Bangalore
10.2017 - 10.2018
- Prepared local product documents and patient information leaflets in line with SOPs and regulatory standards.
- Managed a team of six to ensure timely updates of labeling documents for Malaysia, Brunei, India, and other markets.
- Planned projects to guarantee timely submissions from initial notification to final approval by Health Authorities.
- Collaborated with global teams to efficiently resolve complex issues throughout project lifecycle.
- Conducted monthly stakeholder meetings to align on project progress and address concerns.
- Drafted clear responses to queries from Health Authorities to facilitate communication and transparency.
- Led a team of four to six members, focusing on performance, training, and compliance with standards.
- Reviewed peer author tasks to uphold quality and adherence to established milestones.
Branch Manager
Achievers planet
Dubai
08.2016 - 09.2017
- Counsel students and parents with regards to their queries and admissions.
- Drive the overall academic program of the assigned batches.
- Counsel every student performance to achieve high branch success rate.
- Manage overall smooth functioning of the branch activities such as logistics, finance, audit and academic.
Team Lead - Scientific Writer-Regulatory & Safety (Hub Labeling Manager)
INDEGENE LIFESYSTEMS PVT. LTD.
Bangalore
07.2011 - 06.2016
- Delivered and managed labels using efficient processes to ensure timely approval of product labeling.
- Oversaw label processing for Pharma, Consumer Products, Medical Devices, and Generics.
- Developed labeling documentation including comparison tables and annotated support materials.
- Prepared generic labels for various markets by monitoring innovator labels.
- Conducted gap analysis comparing labels against CDS and other sources.
- Updated CDS based on relevant signals to maintain compliance standards.
- Executed project planning for timely document submission from notification to final HA submission.
- Collaborated with global teams to resolve complex labeling issues.
Education
Maters - Pharmacology
R.G.U.H.S
Bangalore01.2011
Bachelor’s Degree - Pharmacy
R.G.U.H.S
Bangalore01.2008
Skills
- Labeling compliance
- Regulatory submission
- Project management
- Team leadership
- Data management
- Regulatory information management
- Key performance indicators
- Staff development
- Recruiting and interviewing
- Cross-functional collaboration
- Change management
- Stakeholder communication
Languages
- English
- Malayalam
- Hindi
- Kannada
- Tamil
Disclaimer
I hereby solemnly declare that the information provided in the resume is true and accurate to the best of my knowledge and belief.
Personal Information
- Date of Birth: 12/16/86
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Recognition And Rewards
- Spot Award: Awarded for meeting the timelines and quality of high priority task assigned.
- Star of the Month: Awarded for achieving excellent performance and team spirit.
- IPTc Award: recognized as most impactful performers in 2020.
- Silver award: awarded for effectively and excellently leading a special project for South Africa.
Certification
- Regulatory Affairs Certification Program - Pharmaceuticalsls
- First-line leaders' training
Languages
English
First Language
Malayalam
Beginner
A1
Hindi
Beginner
A1
Kannada
Beginner
A1
Timeline
Country Labeling Manager
GSK
10.2021 - Current
Regulatory Specialist - Labelling Coordinator
GSK
10.2018 - 10.2021
Labeling Manager
INDEGENE LIFESYSTEMS PVT. LTD.
10.2017 - 10.2018
Branch Manager
Achievers planet
08.2016 - 09.2017
Team Lead - Scientific Writer-Regulatory & Safety (Hub Labeling Manager)
INDEGENE LIFESYSTEMS PVT. LTD.
07.2011 - 06.2016
Maters - Pharmacology
R.G.U.H.S
Bachelor’s Degree - Pharmacy
R.G.U.H.S
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