Nikesh Babu
Coimbatore
Summary
Regulatory Data and Conformance Manager Associate - II at Pfizer Healthcare India with expertise in ICH compliance and data integrity enhancement. Skilled in managing regulatory submissions and quality assurance, utilizing advanced analytical capabilities in Power BI. Proven track record of successful audit outcomes and commitment to maintaining high operational standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Regulatory Data and Conformance Manager Associate - II
Pfizer Healthcare India Private Limited
Chennai
08.2023 - Current
- Managed and maintained regulatory data across global systems to ensure compliance with internal standards and Health Authority requirements.
- Updated regulatory systems with Chemistry Manufacturing and Controls (CMC) data following submissions and approvals.
- Oversaw regulatory information management processes to support product lifecycle submissions and metadata integrity.
- Performed quality control checks on regulatory documentation to ensure adherence to data governance policies.
- Led data management activities including collection, cleansing, and standardization to enhance regulatory compliance.
- Developed dashboards and visual reports in Excel and Power BI to track key performance indicators.
- Collaborated with cross-functional teams to verify regulatory activities and maintain accurate data records.
- Supported regulatory audits by ensuring timely availability of critical data elements.
Student Intern
KC General Hospital
Bengaluru
06.2022 - 07.2022
- Gained hands-on experience across multiple departments in OPD laboratory, including biochemistry and microbiology.
- Assisted medical staff with diagnostic tests and analysis of patient samples.
- Maintained laboratory equipment and ensured adequate supply levels for efficient operations.
- Contributed to RT-PCR processes and blood bank activities through practical involvement.
Student Intern
Abbes Biotech
Coimbatore
05.2019 - 07.2019
- Acquired practical experience in Gel Electrophoresis for protein and DNA analysis alongside chromatography techniques for biomolecule purification and separation.
Education
Master of Science - Biotechnology
Jain (Deemed-to-be University)
Bengaluru05-2023
Bachelor of Science - Biotechnology
Hindusthan College of Arts And Science
Coimbatore05-2021
Skills
- ICH guidelines and compliance
- Regulatory data and documentation
- Chemistry, manufacturing, and control
- Data validation and reporting
- Regulatory submissions management
- GDP compliance standards
- Regulatory information systems
- Trial master file management
- Good clinical practices (GCP)
- Good manufacturing practices (GMP)
- Clinical trial coordination
- Quality assurance processes
- IDMP standards
- Quality risk management strategies
- Spotfire analytics tools
- Calyx RIM software expertise
- SAP system proficiency
- Microsoft SharePoint utilization
- Microsoft Power BI analysis
- Microsoft Office suite skills
- TrackWise quality management system
- Google Workspace collaboration tools
- Product dossier management expertise
- Adobe Acrobat proficiency
Certification
- Data Stewardship Fluency
- Data Steward Foundations
- Good Clinical Practice
- Drug Development Product Management
- Essential Business Communication Skills
- Project Management: Healthcare Projects
- Career Essentials in Generative AI
- Industrial Biotechnology
- The Science of Stem Cells
- Time Management Fundamentals
Projects
- Centralized Workload Management Dashboard (Pfizer) - Developed a Daily dashboard using Excel and Power BI to track and visualize key operational metrics., Enabled real-time data updates and interactive reporting for improved decision-making.
- SCC 5.0 Tool Launch support and Implementation (Pfizer) - Contributed to the successful launch of the SCC 5.0 tool by supporting data validation, user testing and process alignment activities
Hobbies and Interests
Art & Design, Reading, Editing, World Cinema, Photography, Running, Public speaking
Volunteer Experience
- National Service Scheme (2022 - 2023): Participated in a blood donation camp and conducted an awareness program at a primary school as part of community service initiatives
Community Service
- Rotaract Club of Coimbatore Texcity, (Secretary, 2021 - 2022): Led club activities and hosted “Vinnai Thodu” a speaker session featuring Dr. A. Kaliyamurthy (MA, PhD), Former Superintendent of Police.
- Rotaract Club of Hindusthan College of Arts and Science, (Vice-president, 2018 - 2020): Engaged in community development activities and youth leadership programs
Languages
Tamil
First Language
English
Proficient (C2)
C2
Hindi
Elementary (A2)
A2
References
References available upon request.
Timeline
Regulatory Data and Conformance Manager Associate - II
Pfizer Healthcare India Private Limited
08.2023 - Current
Student Intern
KC General Hospital
06.2022 - 07.2022
Student Intern
Abbes Biotech
05.2019 - 07.2019
Master of Science - Biotechnology
Jain (Deemed-to-be University)
Bachelor of Science - Biotechnology
Hindusthan College of Arts And Science
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