Sonali Parmar has over 11 years of experience in regulatory writing, medical writing, and project management. She has expertise in writing regulatory documents like CMCs and CTDs for US and EU markets. She is proficient in writing clinical study reports, literature reviews, and regulatory documents. Currently she works as a validation consultant for a top pharmaceutical company, providing regulatory and medical writing deliverables.

1. Curriculum
PERSONAL DETAILS
Name : Sonali Parmar
Position : Associate Business Manager
Location : Noida, India
Contact no. : +91 9717180031
e-mail : thakur.sonalijp@gmail.com
Professional Summary: Total 11 years and 8 months of work experience
Management Skills:
• Planning and scheduling project activities to ensure completion of the project within the time and budgetary
parameters and for optimizing resource utilization.
• Proven abilities in project management including project planning, scheduling and monitoring, team management &
training / mentoring.
• Defining, monitoring and collecting project-related metrics.
• Business Development Management : Responding to RFPs
• Manpower management and mentoring – Focusing primarily on demand, supply and deployment of fresher’s as well
as laterals accordingly.
• Fine analytical skills, Excellent English Orator plus good translation of thoughts into written medium as well.
• Well exposed to Quality Procedures under ISO as well as to Six-Sigma best practices.
• Well conversant with MS Office, Documentum software (document generation ), MS Visio, Internet search
• Excellent Interpersonal Skills.
Functional Competencies
a) Medical writing and Regulatory writing skills
 Experience in creation of CMC (Module 3,both 3.2.S and 3.2.P) documents for Regulatory filing of US
 Regulatory documentation, such as full Common Technical Document (CTD) submissions, Chemistry Manufacturing
and Controls (CMC) document.
 Preparation of development reports as per the ICH format, EMEA guidelines and USFDA.
 Documented the Pharmaceutical Quality Module 3 for Dossier preparation as per the regulatory guidance.
 Method development of new products & method validation, master formula development & SOP preparation as
per the ICH GCP guidelines.
 Experience in writing and reviewing different types of Clinical Study Reports (CTD Module 5) such as:
o Full Clinical Study Reports
o Pharma Web Synopsis
o Core Clinical Study Reports
o Brief Textual Summaries
o Abbreviated Reports

2.  Reviewing different types of Safety reports (PSURS and SAE narratives)
 Experience in Commercial Writing: Data extraction from clinical literature reviews, research articles and abstracts in
the fields of Orthopedics and Osteoporosis. Also, worked for Medical devices in writing clinical literature reviews.
 Regulatory writing experience in Clinical modules of CTD ( eg. Clinical Overviews)
 Review of CMC documents ( CTD module 3) in detail to ensure clarity and accuracy of data interpretation, logic,
consistency and compliance with Regulatory requirements
 Review document/regulatory guidelines, templates; understand document content and architecture
requirements; obtain, compile, organize, and interpret data appropriately.
 Involved in Verification and Validation of documents of medical devices as per the GDP and A.S.P.E.N guidance
 Review document/regulatory guidelines, templates; understand document content and architecture
requirements; obtain, compile, organize, and interpret data appropriately
Technical competencies
Research and Development:
 Development of generic formulations for US and EU markets
 Development of Enteric coated tablets, taste masking of drugs using various techniques
 Design and Development of immediate and controlled release tablets, Creams and Gels, development of discriminatory
dissolution media, anti TB Fixed dose combinations.
 Method development of new products & method validation, master formula development & SOP preparation as
per the ICH GCP guidelines.
Professional Experience:
Currently working (April 2014 – present date) as Validation consultant for validation and medical writing deliverables for
top 5 Pharma organization in HCL Technologies, Noida
Previous work experience
Work experience in HCl Technologies
 Associate Business Manager, Regulatory and Medical Writing, HCL Technologies Ltd., Noida, Uttar Pradesh
(February 2009 – May 2013)
 Defect Lead: Techno-functional role in Healthcare domain (April 2011-May 2013)
 Medical writing TL (with a team of 3 members) :
 Medronic review project –CER writing
 Review writing on Knee and HIP implants
 Clinical evaluation systematic literature overview for Pinnacle CER project for DePuy
Orthopaedics
 Reviewing CSRs, Pharma web synopsis and for one of top 5 Pharmaceutical Company
 Reviewing CTD quality module 3 for Drug substance and Drug product

3. Other Key activities as Techno-functional Team Lead:
o Business development activities like project initiation, project execution, framework finalization and
metrics finalization
o Client interaction and requirement analysis
o Providing technical solutions to the team in the team lead role
o Active participant in client meetings for kick off and work review
o Coordination and interaction with client on project planning and issues/concerns
o Worked with technical teams on numerous full life cycle Pharmaceutical projects
o Provided at least 50 trainings to the fresh team on boarded for any Pharmaceutical project
Work experience in previous organizations
1. Organization: Kinapse India Pvt. Ltd. Gurgaon (June 2008 – February 2009).
 Team Lead, Regulatory Writing (worked for GSK and Pfizer) KINAPSE INDIA PVT.LTD. Gurgaon, Haryana
 Roles and responsibilities:
 Experience in creation/ updating CMC (Module 3, both 3.2.S and 3.2.P) of CTD for Regulatory
filing of US, EMEA
 Regulatory documentation, such as full Common Technical Document (CTD) submissions,
Chemistry Manufacturing and Controls (CMC) document.
 Experience in writing and reviewing different types of Clinical Study Reports (CTD Module 5)
such as:
o Clinical Study Reports
o Pharma Web Synopsis
o Core Clinical Study Reports
o Brief Textual Summaries
o Abbreviated Reports
2. Organization: IILM College Knowledge Park -II Gautam Buddha Nagar Greater Noida, Greater Noida, Uttar Pradesh,
India- 201306 (August 2007 – April 2008)
Senior lecturer
Roles and responsibilities:
1. Teaching students of B Pharmacy, Third year and final year
2. Giving sessions on Community Health
3. Organizing events on Pharmacy week
3. Organization: Jubilant Organosys, Noida UP (June 2006 – May 2007)
 Senior Research Scientist and ATL in Jubilant Organosys, Noida, Uttar Pradesh :
Roles and responsibilities:
• Development of generic formulations for US and EU markets along with documentation of
development reports

4. • Development of Enteric coated tablets, taste masking of drugs using various techniques
• Design and Development of immediate and controlled release tablets, Creams and Gels, development
of discriminatory dissolution media, anti TB Fixed dose combinations.
• Art work and documentation of all dosage forms for Regulatory Affairs department.
• Method development of new products & method validation, master formula development & SOP
preparation as per the ICH GCP guidelines.
4. Organization: Panacea Biotec PVT. LTD.Lalru,Chandigarh, Punjab (August 2003 – June 2006).
 Research Associate and Research Scientist
Roles and responsibilities:
o Development of Enteric coated, film coated tablets, taste masking of drugs using various techniques
o Design and Development of immediate and controlled release tablets, Creams and Gels,
development of discriminatory dissolution media, anti TB Fixed dose combinations.
Educational Qualification:
• Masters in Pharmacy (Pharmaceutics)-UIPS, Panjab University, Chandigarh, Punjab.
• Bachelor in Pharmacy- Guru Nanak Dev University, Amritsar.
• GATE qualified in the year 2001 from IIT Karagpur
• WIPO certified (85%) in the year 2004.
• Certified in Regulatory Affairs and Clinical Data Management from IOCB Bangalore
• Thesis work: Organogels as topical formulation for Diclofenac Diethylamine and Dianthranol for Psoriasis
treatment.
Poster presentation
 Organogels : Platform technology for drug permeation via topical route
Seminars presented:
 SUPAC guidelines : Impact on Formulations
 Manuscript writing and PSUR guidance
 Chemistry manufacturing and controls : Regulatory perspective

Strengths & Achievements:
• Good at people Development, Trained several subordinates and Vocational trainees.
• Good presentation skills.
• 2nd Rank secured in the entire University and UGC scholarship holder.

5. Personal Information:
Marital Status: Married
Residential Address: P-1001, Homes 121, Sector 121, Noida 201301.
Permanent Address: Kothi no: 417, Urban Estate Phase 1 Patiala, Punjab, India.

6. Personal Information:
Marital Status: Married
Residential Address: P-1001, Homes 121, Sector 121, Noida 201301.
Permanent Address: Kothi no: 417, Urban Estate Phase 1 Patiala, Punjab, India.