MS office
Mohan Vangala
Lead Regulatory Business Analyst
Khammam,TG
Summary
Experienced and resourceful Lead Regulatory Analyst in the department of Pharma Regulatory Affairs, equipped with a master's degree. Proficient in various modules of the drug development cycle, showcasing a strong background in drafting protocols, amendments, clinical study reports, informed consent documents, case report forms, periodic safety update reports, aggregate reports, and more. Demonstrating meticulous attention to detail, consistently performs quality control checks and proofreading to meet business expectations. Additionally, possesses expertise in data migration to Veeva vault (Tool). Thrives in dynamic environments, excels at adapting quickly, being flexible, and effectively collaborating and working within teams.
Overview
9
9
years of professional experience
22
22
years of post-secondary education
2
2
Certifications
Work History
Lead Regulatory Analyst
CGI Pvt Ltd
11.2018 - Current
- Working with a Team has developed Preparation and analyzing the Regulatory content and mapping the documents of the specific country into Veeva vault environment with the technical team
- Handling of Regulatory repositories of countries eg., Hungary, Finland, Philippines, Bulgaria, and French West Africa (including 26 Countries) and carry out quality check of the mapping documents within team
- Provided clients with assistance as Regulatory specialist and trouble shoot the queries
- Data Migration to Veeva vault (Tool) VRIM suit
- Mentoring and collaboration with new joiners and providing essential trainings to the members
Associate Scientific Writer
Indegene Pvt Ltd
04.2018 - 10.2018
- Delivered excellent administrative services to clients on Systematic literature search, review by using various database search engines (Pubmed, Embase, Ovid and Science Direct etc.,)
- Provide accurate and consistent medical review of advertising and promotional materials on time and minimize review cycles for material approval
- Create and maintain global Reference Product Information/ Company Core Data sheet, based on scientific data in co-operation with the product teams
- Preparation of abstracts, newsletters, and slide decks(promotional & non-promotional materials) for presentation Health care professionals
- Expertise in Veeva Vault promo mats for medical content review/upload.
Medical Writing Officer
Lotus Labs Pvt Ltd (TEVA)
06.2016 - 03.2018
- Regulatory drafting of Protocols, amendments, Clinical Study Reports, Informed Consent Document, Case Report Form for the clinical studies
- Electronic trail master file management (eTMF) of Clinical trial as per the client specification
- Prepared SOP documents for Company Project and Presentation
- Development and review of clinical & nonclinical overviews, summaries, and study reports complying to the CTD format and country specific guidelines
Education
Master of Science - New drug development, Novel Methodologies, Pharmaceutical Development, Drug life cycle
Chaitanya College of Pharmacy Education & Research
Warangal, India 04.2001 - 01.2014
Bachelor of Science - Pharmaceuticals, Pharmacology, pharmacognosy, Physical pharmacy, Medicinal chemistry
Blue Birds College of Pharmacy
Warangal, India 04.2001 - 01.2011
Skills
Veeva Vault Management
Certification
Automation Anywhere Certified - ADVANCED RPA PROFESSIONAL
Awards & Achievements
• Power Performer Award-2021
• Key contributor Award-2022
Accomplishments
- Collaborated with team of 4 in the development of GRACs project.
- Resolved product issue through consumer testing.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Supervised team of 5-6 staff members.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeContract WorkWork Location
On-SiteRemoteHybridImportant To Me
Work-life balanceCompany CultureTeam Building / Company RetreatsWork from home optionFlexible work hoursCareer advancementQuote
I can’t understand why people are frightened of new ideas. I’m frightened of the old ones.
John Cage
Software
Documentum
Data share point
Languages
English
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Telugu
Advanced (C1)
kannada
Advanced (C1)
Interests
Social work
Travelling
Timeline
Lead Regulatory Analyst
CGI Pvt Ltd
11.2018 - Current
Associate Scientific Writer
Indegene Pvt Ltd
04.2018 - 10.2018
Medical Writing Officer
Lotus Labs Pvt Ltd (TEVA)
06.2016 - 03.2018
Master of Science - New drug development, Novel Methodologies, Pharmaceutical Development, Drug life cycle
Chaitanya College of Pharmacy Education & Research
04.2001 - 01.2014
Bachelor of Science - Pharmaceuticals, Pharmacology, pharmacognosy, Physical pharmacy, Medicinal chemistry
Blue Birds College of Pharmacy
04.2001 - 01.2011
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