Open To Work
Anish Guda
Kakinada,AP
Work Preference
Summary
Senior manager with expertise in regulatory compliance and labeling strategy development at Organon. Demonstrated success in cross-functional collaboration and project management, optimizing labeling processes for market readiness. Skilled in digital labeling tools, enhancing efficiency and accuracy in regulatory submissions.
Overview
1
1
Certification
11
11
years of professional experience
Work History
SENIOR MANAGER, GLOBAL LABELING
ORGANON
Mumbai
09.2021 - Current
- Led Regional Labeling and Partnerships, overseeing external vendors for labeling, SPL, and proofreading.
- Developed and maintained target product labeling for developmental products, core labeling documents (CCDS), and US labeling for marketed general medicines and biosimilars to ensure regulatory compliance and support market readiness.
- Collaborated with cross-functional teams to ensure adherence to regulatory requirements and company standards, facilitating timely project delivery.
- Supported local affiliates with EU and ROW labeling, and managed artwork updates for labeling documents.
- Ensured content compliance, constructed MAH responses, and supported SOP updates.
- Created responses for health authority inquiries regarding labeling to ensure compliance.
- Implement initiatives for simplifying the labeling development process.
- Proficient in Power BI and Power Automate tools to analyze data and streamline workflows.
REGULATORY AFFAIRS SPECIALIST (GLOBAL REGULATORY AFFAIRS)
IQVIA
Bangalore
05.2021 - 09.2021
- Managed the Global Labelling Oversight Committee process for the assigned product portfolio.
- Coordinated responses to Health Authority (HAs) and Local Operating Companies (LOCs) queries to facilitate timely regulatory approvals.
- Maintained Company Core Data Sheet (CCDS) throughout lifecycle of medicinal products to ensure regulatory compliance and support product safety.
- Updated Global Labelling trackers and Regulatory Information Management systems to enhance accuracy and accessibility of regulatory information.
- Managed and maintained Global Labelling databases and systems.
- Implemented Local Product Information within set timelines.
- Provided input to Reference Safety Information (RSI) for PSURs/PBRERs.
- Collaborated with GSK on labeling projects.
- Acted as labeling specialist on regulatory projects.
ASSOCIATE TO TEAM LEAD REGULATORY OPERATIONS
FREYR SOFTWARE SERVICE LTD
Hyderabad
08.2015 - 05.2021
- Develop and maintain core labeling (CCDS/CSI, CCPPI, CCIFU), US, EU, and ROW markets.
- Provided strategic and operational regulatory labeling input to guide project direction.
- Collaborate with client Regulatory Affairs, Clinical, Nonclinical, Medical, Safety, and QPPV Experts.
- Provide project management support throughout the labeling process.
- Ensured compliance and quality of labeling documents, supporting regulatory approval processes.
- Created comparison tables to identify deviations, enhancing reporting accuracy.
- Create label justification documents using literature.
- Client: Merck & Co. and Pfizer
- Project: Global Labeling Lead
Education
M. Pharmacy - Pharmaceutical Technology
Andhra University
12-2013
B. Pharmacy - Physiology, Pharmaceutics
Andhra University
03-2011
Intermediate (Bi.P.C) - Botany, Zoology, Physics, Chemistry
04-2006
Skills
- Labeling strategy development
- Regulatory compliance assurance
- Labeling systems expertise
- Digital labeling knowledge
- User acceptance testing
- Project management
- Migration planning
- Data management proficiency
- Cross-functional collaboration
- Training and support services
- MS tools proficiency
- Labeling strategy
Certification
- Diploma in Clinical Research and Clinical Data Management, Institute of Good Clinical Practice, 2014.
- Google Project Management Professional Certificate, developing skills in project planning, execution, Agile methodologies (including Scrum), risk management, and stakeholder communication.
Languages
- English
- Telugu
- Hindi
Disclaimer
I hereby declare that the information furnished above is true and genuine.
Area Of Expertise
- Labeling strategy and development/maintenance
- Cross functional teams’ collaboration
- Ensure compliance with regulatory requirements
- Labeling database and systems: Veva Vault (RIM, RADR, BDLM), ENNOV, LEAPS, PFLEET, RCAM. Data Management, Migration & UAT | Data Management Systems | Training & Support
- Knowledge and Expertise in Digital Labeling (FHIR)
- Proficient MS tools including Power BI, Automate
Personal Information
- Father's Name: Guda Venkata Ramana
- Date of Birth: 10/07/89
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
English
Proficient (C2)
C2
Telugu
Native
Native
Hindi
Proficient (C2)
C2
Affiliations
- Community Outreach Volunteer
Nonprofit Organization | 2023 – Present
Assisted with awareness campaigns focused on accessibility and social inclusion.
Participated in volunteer-driven events and community engagement programs.
Supported planning and coordination activities alongside volunteer teams. - Accessibility & Inclusion Volunteer
Community Support Initiative | 2024 – Present
Participated in programs promoting accessibility and inclusive community engagement.
Assisted in organizing awareness activities and support events for individuals with physical disabilities.
Collaborated with volunteers to improve participation and event coordination.
Advocated for inclusive environments and equal access initiatives.
Accomplishments
- MSD Superstar Award - 2020
This award is given to individuals who are top team players, meet deliverables on time with quality, exhibit some leadership qualities, mentor/support other team members, help resolve issues with solutions within a team, and also contribute ideas for innovation, being proactive in communication. - MSD EUREKA AWARD - 2019
This award is given to the individual who has brought out the smartest/best idea supported in implementing it, leading to significant business impact.
Timeline
SENIOR MANAGER, GLOBAL LABELING
ORGANON
09.2021 - Current
REGULATORY AFFAIRS SPECIALIST (GLOBAL REGULATORY AFFAIRS)
IQVIA
05.2021 - 09.2021
ASSOCIATE TO TEAM LEAD REGULATORY OPERATIONS
FREYR SOFTWARE SERVICE LTD
08.2015 - 05.2021
M. Pharmacy - Pharmaceutical Technology
Andhra University
B. Pharmacy - Physiology, Pharmaceutics
Andhra University