Shailendra Bhandarkar
Drug Regulatory Affairs
Panipat
Summary
Self-motivated Regulatory Affairs Associate holding 13 years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities.
Overview
14
14
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
AGM – Drug Regulatory Affairs
Medcell Pharma
Panipat
01.2021 - Current
Senior Manager – Drug Regulatory Affairs
Laborate Pharmaceutical India Ltd.
Panipat
08.2011 - 12.2020
- Providing leadership, direction, and guidance for regulatory affairs
- Compilation and review of dossiers in CTD, ACTD, and regional formats as per regulatory guidelines
- Review of administrative (Module 1) and quality (Modules 2 & 3/CMC) dossier sections
- Timely preparation and submission of regulatory dossiers
- Product registration across multiple countries, including Kenya, Malawi, Madagascar, Uzbekistan, Cambodia, Sri Lanka, Philippines, Lebanon, Iraq, Ecuador, Venezuela, and more
- Review and compilation of quality and analytical data, stability protocols, pharmacological, pre-clinical, and toxicological data
- Preparation and submission of company registration documents
- Handling international tenders and submissions
- Artwork development and compliance with SmPC, PIL, and labelling guidelines
- Reviewing bioequivalence study reports and biowaiver (in-vitro dissolution reports)
- Coordinating with various departments for dossier compilation
- Managing COPP issuance, post-approval changes, compliance reports, and CAPA
Education
Master of Pharmacy (M. Pharm.) - Pharmaceutics
RGPV University
Bhopal 10.2008 - 12.2010
Bachelor of Pharmacy (B. Pharm.) -
RGTU University
01.2005 - 10.2008
Diploma in Quality Control and Quality Assurance -
IPER
PuneGATE Qualified - undefined
IIT Bangalore
Skills
- Regulatory Knowledge: ICH
- WHO-GMP
- US-FDA
- Drug & Cosmetic Act 1940
Dossier Preparation: CTD
- ACTD
- DMF
- SmPC
- PIL
- Labelling
- Market Expertise: ASEAN
- CIS
- LATAM
- Africa
- Asian markets
- Analytical & Compliance: Biowaivers
- Bioequivalence studies
Compliance assurance
Quality management systems
International regulations
Pharmaceutical regulations
Regulatory submissions
ICH guidelines
Document management
Submission preparation
Regulatory training
Regulatory affairs certification
License renewals
Regulatory inspection readiness
Regulatory audits
Product information
Data verification
Teamwork
Teamwork and collaboration
Problem-solving
Problem-solving abilities
Leadership skills
Multitasking ability
Decision-making
Document preparation
Self motivation
Critical thinking
Effective communication
Team collaboration
Roles And Responsibilities
- Providing leadership, direction, and guidance for regulatory affairs.
- Compilation and review of dossiers in CTD, ACTD, and regional formats as per regulatory guidelines.
- Review of administrative (Module 1) and quality (Modules 2 & 3/CMC) dossier sections.
- Timely preparation and submission of regulatory dossiers.
- Product registration across multiple countries, including Kenya, Malawi, Madagascar, Uzbekistan, Cambodia, Sri Lanka, Philippines, Lebanon, Iraq, Ecuador, Venezuela, and more.
- Review and compilation of quality and analytical data, stability protocols, pharmacological, pre-clinical, and toxicological data.
- Preparation and submission of company registration documents.
- Handling international tenders and submissions.
- Artwork development and compliance with SmPC, PIL, and labelling guidelines.
- Reviewing bioequivalence study reports and biowaiver (in-vitro dissolution reports).
- Coordinating with various departments for dossier compilation.
- Managing COPP issuance, post-approval changes, compliance reports, and CAPA.
Skills And Expertise
ICH, WHO-GMP, US-FDA, Drug & Cosmetic Act 1940, CTD, ACTD, DMF, SmPC, PIL, Labelling, ASEAN, CIS, LATAM, Africa, Asian markets, Biowaivers, Bioequivalence studies, CAPA, Change Control, MS Word, Excel, Google Docs, Adobe Acrobat, Nitro PDF, Photoshop, Written communication, Verbal communication, Negotiation Skills, Planning and co-ordination, Problem Solving, Risk Management, Team Collaboration, Critical and analytical Skills
Audit Exposure
- Assisted in audits by MOH
- NAFDAC (Nigeria)
- PPB (Kenya)
- NMRA (Sri Lanka)
- NDA (Uganda)
- WHO-GMP
- MOH Yemen
Personal Information
- Date of Birth: 03/11/86
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Training
- Dubai Arab Health Care (2023, 2024, 2025)
- CPHI 2024 (Noida)
- IPHEX 2023, IPHEX 2024
Disclaimer
I hereby declare that the information provided above is true and accurate to the best of my knowledge.
Personal Traits
- Reliable, detail-oriented, and proactive professional
- Strong decision-making and problem-solving abilities
- Excellent interpersonal and communication skills
- Ability to work effectively under pressure and in team environments
Devotional songs, Reading News Paper
Bhajan and NEWS
Timeline
AGM – Drug Regulatory Affairs
Medcell Pharma
01.2021 - Current
Senior Manager – Drug Regulatory Affairs
Laborate Pharmaceutical India Ltd.
08.2011 - 12.2020
Master of Pharmacy (M. Pharm.) - Pharmaceutics
RGPV University
10.2008 - 12.2010
Bachelor of Pharmacy (B. Pharm.) -
RGTU University
01.2005 - 10.2008
GATE Qualified - undefined
IIT Bangalore
Diploma in Quality Control and Quality Assurance -
IPER
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