Open To Work
Sapna Farswan
Ghaziabad
Summary
Senior executive in regulatory affairs with expertise in CTD/ACTD dossier preparation and compliance with CDSCO and EUDAMED regulations. Experienced in managing international submissions in African and Asian markets, collaborating with quality control, quality assurance, and production teams. Proven ability to engage stakeholders, review documentation, and support CE surveillance and ISO 13485 audits. Focused on driving operational efficiency and implementing policies that enhance performance and ensure sustainability.
Overview
5
5
years of professional experience
Work History
Senior Executive RA
Zuche pharmaceutical pvt. Ltd.
New Delhi
2025.02 - Current
- Coordinated cross-functional teams, ensuring successful product development and regulatory compliance.
- Facilitated communication across departments to improve workflow and meet project timelines.
- Led strategic initiatives that enhanced operational efficiency in pharmaceutical processes.
- Implemented rigorous quality control measures maintaining production standards.
- Established strong relationships with key stakeholders and vendors for optimal project outcomes.
- Conducted thorough market analysis identifying new business opportunities.
- Developed comprehensive training programs to boost staff performance.
- Created detailed reports tracking organizational progress toward set goals.
Executive Drug Regulatory Affairs
Theon Pharmaceuticals Ltd.
Panchkula
2024.07 - 2025.01
- Ensured documentation compliance for international submissions per regulatory guidelines and pharmacopoeia standards.
- Reviewed documents for regulatory agencies, including process validation protocols and stability data reports.
- Evaluated specifications for stability data and packaging materials to confirm regulatory compliance.
- Compiled and assessed dossiers in CTD and ACTD formats according to current regulatory standards for Africa and Asia.
- Coordinated with QC, QA, and production teams to align efforts with regulatory requirements.
- Resolved inquiries from ministries and regulatory agencies in Tanzania, Kenya, and Sri Lanka, ensuring clarity and compliance.
- Assessed product labels and inserts for accuracy and adherence to established regulatory guidelines.
- Managed medical device regulatory activities, including EUDAMED registration and documentation for notified bodies.
Officer- Drug Regulatory Affairs
Verve Human Care Laboratories (A unit of Venor Pharma Ltd.)
Selaqui
2023.07 - 2024.07
- Conducted testing of software and systems to verify quality and reliability, supporting regulatory compliance.
- Updated and maintained databases to ensure accuracy and compliance with regulatory standards.
- Managed daily operations of laboratory equipment and supplies.
- Ensured compliance with safety regulations and laboratory protocols.
- Conducted routine quality checks on samples and reagents.
Jr. Officer- Drug Regulatory Affairs
East African (INDIA) Overseas
Selaqui
2021.02 - 2023.07
- Managed daily operations, ensuring adherence to company policies and regulatory requirements.
- Developed and maintained strategic relationships with key clients and stakeholders to enhance collaboration and communication.
- Created actionable plans addressing operational challenges to improve efficiency and optimize resource allocation.
- Developed and maintained relationships with key clients and stakeholders.
- Led training and development programs to enhance team skills and performance.
- Strengthened team dynamics through effective communication with colleagues and supervisors.
- Utilized document management system to organize company files, keeping up-to-date and easily accessible data.
Education
Masters - Biochemistry
Hemvati Nandan Bahuguna Garhwal University
Srinagar Garhwal University Uttarakhand 2020-01
Bachelor - Science
H.N.B. Garhwal University
Srinagar Garhwal Uttarakhand2018-01
Higher Secondary Exam -
Government Girls Intercollege Tharali
Chamoli, Uttrakhand2015-01
Secondary Exam -
Jawahar Navodaya Vidyalaya
Pipalkoti, Chamoli2013-01
Skills
- Regulatory compliance and affairs
- Quality control and assurance
- Risk management
- Market analysis
- Budget forecasting
- Business case development
- Project coordination
- Strategic initiatives
- Change management
- Stakeholder engagement
- Cross-functional collaboration
- Team leadership
- Analytical skills
- Problem solving
- Document management
- Performance evaluation
- Data management
- Computer proficiency
- Public speaking
Job Profile
ROW Market, Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities, CTD & ACTD Format (African, Asian Countries)., Ensured documentation complies with regulations for the international submissions as per the regulatory guidelines of respective ministry., Review specifications- MOA, STP, stability & Finished product /Packaging material data for the purpose of compilation of Dossier., Review of documents required for regulatory agencies (Viz. Process validation protocols, Process validation reports, Pharmaceutical development reports, Stability protocols and Data)., Coordination with QC, QA & Production department for regulatory requirements., To handle the query from ministry of Tanzania, Kenya, FDA Myanmar, NMRA Sri Lanka and other local customers., Review of Labeling information & package insert.
Technical Skills & Digital Tools
- AI Applications & Prompt Engineering
Hands-on experience with leading AI platforms such as ChatGPT, Gemini, Claude, and Microsoft Copilot for regulatory documentation drafting, query response preparation, and dossier formatting. Skilled in prompt writing to generate accurate, compliance-ready outputs tailored to regulatory authority requirements. - Regulatory Portals
- Sugam Portal (CDSCO): Proficient in NOC filing, dossier submission, and query handling.
- EUDAMED & EUMDR Systems: Experienced in technical file preparation, registration, and brand addition to Notified Bodies.
- Productivity Tools
- Microsoft Excel: Data compilation, stability data analysis, and tabular presentation of regulatory information.
- Microsoft Word: Drafting dossiers, regulatory responses, and audit documentation.
- Microsoft PowerPoint: Preparing compliance presentations, audit summaries, and training materials for cross-functional teams.
Affiliations
- Undergone online training in Molecular Biology and Biochemistry Techniques with
EDUFABRICA in association with SPRINGFEST IIT Kharagpur (October 25, 2020 –
November 3, 2020).
One month of training in Clinical Biochemistry, tools, and techniques with DNA Labs - A
Center for Applied Sciences (DLCAS) Dehradun (from December 28, 2020, to January 30,
2021).
Personal Information
- Father's Name: Harpal Singh Farswan
- Mother's Name: Pushpa Devi
- Date of Birth: 04/25/99
- Nationality: Indian
- Marital Status: Married
Languages
Hindi
Native
Native
English
Advanced (C1)
C1
Disclaimer
I hereby declare that the information provided above is true and correct to the best of my knowledge and belief. Nothing has been concealed or misrepresented, and I take full responsibility for the accuracy of the details mentioned herein.
Work Preference
Job Search Status
Open to workSalary Range
₹45000/yr - ₹200000/yrTimeline
Senior Executive RA
Zuche pharmaceutical pvt. Ltd.
2025.02 - Current
Executive Drug Regulatory Affairs
Theon Pharmaceuticals Ltd.
2024.07 - 2025.01
Officer- Drug Regulatory Affairs
Verve Human Care Laboratories (A unit of Venor Pharma Ltd.)
2023.07 - 2024.07
Jr. Officer- Drug Regulatory Affairs
East African (INDIA) Overseas
2021.02 - 2023.07
Masters - Biochemistry
Hemvati Nandan Bahuguna Garhwal University
Bachelor - Science
H.N.B. Garhwal University
Higher Secondary Exam -
Government Girls Intercollege Tharali
Secondary Exam -
Jawahar Navodaya Vidyalaya