Shweta Chugh Ghai is seeking a position in regulatory affairs and compliance that offers professional growth. She has over 8 years of experience in regulatory affairs. Currently, she works as a Senior Regulatory Associate at Kinapse India, where she leads regulatory evaluations and prepares CMC regulatory submissions. Previously, she worked at Panacea Biotec and PanEra Biotec, where she prepared domestic and international dossiers and responded to regulatory queries. She has a MBA in Operations Management and M.Sc. in Biotechnology.

1. SHWETA CHUGH GHAI
Address
H.No 393 , Sec 37
Faridabad Haryana.
Ph.: +91-9810568007.
E mail: shwetachugh1104@yahoo.co.in
Objective:
Seeking a position that offers professional growth while being resourceful, innovative and flexible
and to utilize all the skills and abilities that I have augmented and to garner appreciation and
make the organization I work for proud of me.
Area of Interest:
Regulatory Affairs and Compliance.
Total Experience: 8 years 11 months
Currently employed with:
• Kinapse India: Providing Life Sciences Consulting and Outsourcing services to the
global life sciences industries. http://www.kinapse.co.uk/
• Working as Senior Regulatory Associate –CMC Strategic Author.
Job Profile:
• Actively lead regulatory evaluation and assume responsibility for own function strategic
project work.
• Proactively communicate CMC regulatory strategy, key issues and other critical topics
throughout the lifecycle to Client Team Leader/Strategic Team Leader (and Program
Leader, if warranted) to meet contractual agreement.
• Prepare and author all variants of CMC Quality submission components in line with
functional team expectations (e.g. QoS, Module 3, Agency Queries, etc.) under minimal
supervision.
• Prepare post approval changes for legal entity name changes for EU and MoW
markets.
• Collaborate with Client and or Strategic Team Leader to ensure that strategic priorities for
the projects are understood and implemented.
• Implement and drive CMC submission activities (planning, review, co-ordination and
submission) for assigned projects/products
• Prepare quality updates and manage the CMC lifecycle of projects.
• All quality documents to be prepared using Client GCMC templates, using regulatory
intelligence provided by technical teams/databases, maintained appropriately within
Client’s systems e.g. Global Documentation Management System (GDMS), PDM.
• Maintain all Kinapse and Client quality and tracking systems.

2. Past Experiences:
• Previously worked with Panacea Biotec.Ltd, New Delhi in Regulatory Affairs as Executive
Regulatory affairs.
• Previously worked with PanEra biotec (an association of Panacea Biotec at lalru,
Chandigarh, India) as Scientific officer in Production of vaccines
Job Profile @ Panacea
• Prepare dossiers for Domestic market as per CTD Format (CDSCO)
guidelines (H1N1,Anthrax ,Pentavalent ,hexavalent , polio vaccine etc)
• Preparing dossiers for Rest of the World countries in compliance with ICH-CTD, ACTD,
for emerging markets as per country specific guidelines, to refer USFDA and EU as
well.
• Responding to the queries received from NRA or other concerned regulatory bodies
(country specific).
• Ensuring that a company’s product comply with the regulations of the regulatory
requirement of different countries.
• Keeping up to date with company’s product range.
• Responsible for reviewing documents of Drug substance and Drug product eg. Sop’s,
Batch records, Package inserts, Summary of product characteristics and Patient
Information Leaflet.
• Reporting SAE’s to the concerned regulatory authorities within the time frame.
• Review of technical documents like Finished Product Specifications, Raw Material
Specifications, Certificate of Analysis and Stability Studies etc.
• To assist the external auditors while their visit to the manufacturing plant and provide
them with the required supporting documents during audit.
Skills developed at PanEra Biotec Pvt. Ltd. (Production and QA)
• Hands on experience of working in cGMP conditions and a facility approved by WHO
• Achieving the set production target well on time.
• Purification of antigens by Downstream Processing (aP, Diphtheria, wP)
• Upstream processing of Recombinant Hepatitis B surface antigen
• Validation and revalidation of process and equipments.
• Training and retraining of personnel in production.
• Co-ordinating intradepartmental activities
• Implementing a healthy channel mix with other departments.
• Ensure the Environmental monitoring of production area as per GMP requirements.
• Conducted internal audits of QA, QC, warehouse etc.
Scholastic Background:
• Completed MBA in Operations Management from Symbiosis, Pune (distance
learning)
• M.Sc (Biotechnology); 2007, CGPA 8.2 from Amity University, Noida, U.P.
• B.Sc (Biotechnology);2005, 76% from Mody Institute of Education & research, Jaipur

3. Project Work in M. Sc
• Completed 6 months dissertation from All India Institute of Medical sciences, New
Delhi (in ocular biochemistry)
Proficiencies:
 Platforms : WINDOWS
 Application : MS Office

4. Personal details:
Name : Shweta Chugh Ghai
Husbands Name : Mr. Ashish Ghai
Date of Birth : 26th
June 1984
Sex Female
Marital Status Married
Languages Known English, Hindi & French
References:
Shall be provided on request
Declaration:
I hereby declare that the above information is true to the best of my knowledge.
Date:
Place: New Delhi
(Shweta Ghai)