Hema Latha
Regulatory Affairs Labelling Manager @Haleon
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Labelling Manager @Haleon
In collaboration with all stakeholders (e.g. Regulatory Categories, Consumer Safety Sciences, Clinical and Medical) and for a sub-category, brand or portfolio of products:• Update the GDS in line with established processes and systems.• Create and revise the supportive documentation required for GDS approval at HSB. • Present the GDS update and supportive documentation for approval by the HSB.• Plan, prepare and deliver high quality regulatory files supporting local submission.• Manage country labelling differences and support CLD process according to agreed standards.• Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.• Ensure compliance of their actions by adhering to established processes, policies, SOPs and working instructions.• Provide Labelling expertise/information for RA activities (e.g. renewal, PBRERs).If applicable,• Prepare GDS compliance metrics for presentation at GROC and complete follow up activity when required to ensure timely implementation of GDS updates in local markets.• May act as labelling SME to support successful implementation of Regulatory Information Management systems, and act as SME for other regulatory systems and repositories as required.• Provide training on labelling processes for Global and Regional RA.• Support continuous improvement of labelling process and direct new policy or pioneer new processes or improvements to Haleon\'s competitive advantage.• May act as Haleon representative to external groups on specific task forces within labelling expertise (e.g. digital e-leaflet).
EDUCATION
DAV Centenary Public School
1 to 10th
Aditya Institute of Pharmaceutical Sciences and Research Organization
B.Pharmacy
SASTRA University
Master's degree
SKILLS
ABOUT HEMA LATHA
Regulatory Affairs Labelling Manager In collaboration with all stakeholders (e.g.…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.