Angelin P Christopher
Brantford
Summary
Experienced professional with over 9 years of experience in regulatory writing, clinical trials, and project management within the healthcare and medical device sectors. Skilled in EU MDR, FDA, Health Canada, and PMDA regulations, with a proven ability to lead cross-functional teams and deliver complex projects on time and within budget. Committed to continuous improvement, innovation, and ensuring compliance, while seeking new challenges to leverage my skills in dynamic and evolving environments.
Overview
11
11
years of professional experience
Work History
Assoc Lab Project Services Manager
Iqvia RDS (India) Private Limited
11.2023 - 05.2024
- Led clinical trial lab projects, ensuring adherence to timelines, budgets, and compliance.
- Managed project teams across regions, facilitated communication with clients, and tracked milestones in Smartsheet.
Project Lead - Scientific Writing
Indegene Inc
04.2022 - 10.2023
- Authored and reviewed regulatory documents (Clinical evaluation and Post-market surveillance) for compliance with global regulations.
- Mentored a team of 15 and optimized QARA processes, improving resource utilization.
Specialist - Aggregate Reporting
ClinChoice Pvt Ltd
07.2021 - 04.2022
- Prepared and reviewed 20+ PSURs, ensuring compliance with MDR regulations.
- Developed QC checklists and provided training to new hires.
Senior Medical Writer
HCL Technologies
10.2018 - 04.2021
- Authored clinical evaluation reports (CERs) and regulatory documents for CE Marking, ensuring compliance with MDR and MEDDEV guidelines.
- Conducted scientific literature searches and analyzed clinical data for medical devices.
Content Writer
Lumina Datamatics
04.2018 - 10.2018
- Developed educational content for textbooks on microbiology and biotechnology.
- Drafted alternative text for images, tables, and charts.
Research Scholar
AMET University
07.2013 - 01.2017
- Conducted research, published 12 peer-reviewed articles, and presented 7 papers at international conferences and seminars.
- Co-supervised undergraduate and postgraduate research projects, delivered lectures for M.Sc. and B.E/M.E programs, and assessed student performance to support academic development.
Education
Ph.D. - Marine Biotechnology
AMET University
01.2021
M.Sc. - Biotechnology
Sathyabama University
01.2012
B.Sc. - Biotechnology
Sathyabama University
01.2010
Skills
- Regulatory Writing: CERs, PMSRs, PSURs, CEPs, SSCP
- Regulatory Standards: EU MDR, FDA, Health Canada, PMDA
- Clinical Trials: Documentation and claims evaluation
- Project Management: Planning, risk assessment, leadership
- Research & Data Analysis: Research methodologies and data interpretation
- Technical Tools: Smartsheet, MS Teams, PerfectIT, Endnote
- Quality Assurance: Scientific writing and regulatory documentation
Accomplishments
- Make it Happen Award – Indegene Pvt Ltd: Delivered 22 high-quality documents in 6 months.
- Enterprise Risk Champion Award – HCL Technologies: Won Risk and Compliance contest.
- First Prize – NASHE’16: Oral Presentation at Sathyabama University.
Key Accomplishments
- Make it Happen Award – Indegene Pvt Ltd: Delivered 22 high-quality documents in 6 months.
- Enterprise Risk Champion Award – HCL Technologies: Won Risk and Compliance contest.
- First Prize – NASHE’16: Oral Presentation at Sathyabama University.
Timeline
Assoc Lab Project Services Manager
Iqvia RDS (India) Private Limited
11.2023 - 05.2024
Project Lead - Scientific Writing
Indegene Inc
04.2022 - 10.2023
Specialist - Aggregate Reporting
ClinChoice Pvt Ltd
07.2021 - 04.2022
Senior Medical Writer
HCL Technologies
10.2018 - 04.2021
Content Writer
Lumina Datamatics
04.2018 - 10.2018
Research Scholar
AMET University
07.2013 - 01.2017
M.Sc. - Biotechnology
Sathyabama University
B.Sc. - Biotechnology
Sathyabama University
Ph.D. - Marine Biotechnology
AMET University
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