Sakshi Sinha
New Delhi
Summary
Experienced Regulatory Affairs professional with expertise in CDSCO guidelines and regulatory submissions for cosmetics in India. I bring efficiency in regulatory processes and minimizing regulatory risks, contributing to the organization's compliance and operational success.
Overview
4
4
years of professional experience
Work History
Junior Regulatory Affairs
NKG Advisory Business & Consulting Services Pvt. Ltd.
Pitampura, New Delhi
04.2024 - Current
- Assisted in preparing and submitting regulatory dossiers in compliance with CDSCO guidelines for new product registrations and renewals.
- Coordinated with clients to collect necessary documentation and information for regulatory submissions, ensuring accuracy and timely delivery.
- Managed trackers and documentation to support project workflow, enabling efficient tracking of regulatory activities and deadlines.
- Collaborated with industry experts to enhance knowledge and build a strong foundation in Regulatory Affairs , contributing to the department's overall success.
- Gained hands-on knowledge of COS 2 and COS 4 applications , bulk import of cosmetics, additional pack size applications , additional variant applications, change of legal entity applications , contributing to the submission and approval process for cosmetic product registrations.
- Acquired a basic understanding of medical device import processes in India , including regulatory requirements and compliance with local authorities such as CDSCO.
Technical Assistant
Raj Pharma Consultancy
New Delhi
06.2021 - 06.2021
- Gathered, organized and distributed technical documentation.
- Provided technical guidance and support to team members.
Education
M. Pharm (Drug Regulatory Affairs) - Pharmacy
Amity University
Noida, Uttar Pradesh05-2024
B.Pharm - Pharmacy
Amity University
Noida, Uttar Pradesh05-2022
Skills
- Documentation Management
- Regulatory Submissions
- Microsoft Office Suite (Excel, Word, PowerPoint)
- Data Management
- Time Management
- Communication
- Attention to Detail
Timeline
Junior Regulatory Affairs
NKG Advisory Business & Consulting Services Pvt. Ltd.
04.2024 - Current
Technical Assistant
Raj Pharma Consultancy
06.2021 - 06.2021
M. Pharm (Drug Regulatory Affairs) - Pharmacy
Amity University
B.Pharm - Pharmacy
Amity University
Similar Profiles
CS NEETIKA GUPTACS NEETIKA GUPTA
Senior Executive-CS & Compliances at UJA - International advisory and Business Consulting FirmSenior Executive-CS & Compliances at UJA - International advisory and Business Consulting Firm
JOHN R. BOUSTANIJOHN R. BOUSTANI
Consultant – Paint & Injection Molding Processes Engineering at Belcan Companies Advisory & Consulting ServicesConsultant – Paint & Injection Molding Processes Engineering at Belcan Companies Advisory & Consulting Services
Jose Ignacio Rodriguez MartinezJose Ignacio Rodriguez Martinez
Business Development Manager at OCA Global Consulting and Advisory Services S.L.Business Development Manager at OCA Global Consulting and Advisory Services S.L.