1. Curriculum Vitae
RAGINI NIKAM
CAREER SUMMARY:
Feb 2012 – Present
Genpact Pharmalink Consulting Pvt Ltd
Lead Associate
GCMC Established Product Team
I am working on following assignments;
 Renewals : Colombia, Ecuador, Ghana, Macedonia
 Query Responses : Poland, Slovenia, Sweden, Switzerland, Thailand
 Variation package: Chile, Mexico, Jordan, Iran, Qatar, UAE, Bahrain, United States
 Rework packages : Chile, China, Korea, Nigeria
• I author or update the CMC sections as per the country requirements.
• I request & review Ancillary documents.
• I prepare Quality Overall Summary.
• Filled application form as well as prepared Cover letter for variation of US.
• I have provided the Technical support for below assignments;
 Query response
 Initial submission
 License withdrawal
 Commitment Tracking
 Variation (Specially of EU)
 Change withdrawal
 Second Brand submission
 Preparation of QOS
 Renewals
GCMC Ancillary/Regional Documentation Team:
• I have done following activities in Ancillary Team;
 Handled client’s various systems.
 Requested, collected, compiled and reviewed CMC Ancillary Documents as well as Legalized Certificates
(e.g. GMP, ML) received from manufacturing site.
 Communicated with CMC Strategist for queries related to requests also queries received from site
regarding documents.
 Prepared documents Ready for Submission for publishing stage.
 Also communicated with manufacturing sites or respective labs to request documents as well as to convey
the discrepancies found in the received documents
 Handled rework requests.
 Received and answered queries from site/CMC strategist regarding documents.
 I have worked on following projects for mentioned countries;
Initial Submission: Brazil, Chile, Mexico, Venezuela, Uzbekistan, Italy, France, Brazil, Morocco,
Turkey, Ukraine
Renewals: Israel, Sri Lanka, El Salvador, Belarus, Uruguay, Kazakhstan, Bolivia, China, Estonia,
Aruba, Peru, Costa Rica, Colombia, Austria, Czech Rep, Ireland, Latvia, Netherland, Norway, Spain,
Sweden, U.K., Honduras, Albania, Egypt, Sudan, Kuwait, Oman, Panama, Bosnia & Herzegovina,
Ukraine, Iraq, Armenia, Azerbaijan, Benin, Cameroon, Togo, Cote dlvoire, Ecuador, Ghana, Morocco,
Ecuador, Ukraine, Tunisia, Macedonia, Yemen, Mexico, Vietnam, Guatemala, Nicaragua, Jordan,
Address: ‘Nikam Nivas’, behind Rahul Appt, E-mail: rynikam@gmail.com
Kadam Wadi road, Ph: 9773025880
Marol Pipe Line,
Andheri (East),
Mumbai-400059

2. Curriculum Vitae
RAGINI NIKAM
Croatia, Iran, Brazil, Bahrain, Curacao, UAE, Saudi Arabia, Philippines, Madagascar, Uzbekistan,
Kyrgyzstan.
Variation: Canada, Tunisia, Morocco, Algeria, Venezuela, Albania, Croatia, Hungry, Russia, Canada,
Ukraine, China, Italy
Query: Italy, Ukraine, Jordan, UAE, Iraq, Mexico, Malaysia, Colombia, Israel
Post Approval: Kuwait
Second Brand Submission: EU
PNS Submission: Russia
GCMC Emerging Markets Team:
• I have done below assignments in EM Team;
• Prepared dossiers in CTD format as per countries guidelines for Semi regulated markets.
• Markets are;
 AfME Countries: International Registration Dossier (IRD) - Ghana, Uganda, Nigeria, Ethiopia, Tanzania,
Iraq; Redacted- CTD (R-CTD) - Egypt, Kenya, Sudan, Algeria
 CIS: Georgia, Azerbaijan
 South America: Uruguay
• Prepared ‘Query Response’ for Saudi Arabia, Ethiopia, Brazil, Egypt, Azerbaijan
• Provided support to “Commitment Tracking Project”
• Prepared ‘Variation package’ for Brazil
• Provided ‘Technical support’ for Ethiopia, Brazil, Egypt, Azerbaijan, India
• Supported ‘2nd Brand Submission’ for Brazil
Others:
• Worked for ‘Module 4 -5’ (CTD) and ‘Part 3-4’ (ACTD) for UK dossier build
• Worked for ‘Clinical Trial Label’ Review
Sept 2010 – Jan 2012
Lyka BDR International Ltd
Regulatory Affairs Officer
• I have prepared dossier in CTD, ACTD formats as per countries guidelines for Semi regulated and non-
regulated countries and also handled Drug Master Files.
• Prepared dossiers for;
 ASIA: Myanmar, Philippines, Sri-Lanka, Thailand, Vietnam, and Maldives
 CIS: Kazakhstan, Russia, Ukraine, Uzbekistan, Moldova, and Turkmenistan.
 AFRICA: Ghana, Kenya, Sudan, Uganda, Nigeria, Sierra Leone, Mozambique, RD – Congo
 CENTRAL & NORTH AMERICA: Panama, Costa Rica, Guatemala
 SOUTH AMERIA: Chile, Cambodia, Venezuela.
• I have handled documents from R&D, Q. A., Q. C. and Production departments like DMF, Validations, COAs,
some other legal documents like GMP, COPP and Manufacturing License etc.
• I am well versed with MS Office and Internet Application.

3. Curriculum Vitae
RAGINI NIKAM
TRAININGs:
• Q.C. & Microbiology & Production Department – INGA Pharmaceuticals (Jun-2007)
• RND, Microbiology, Q.C., Color, Production Department - M/s. Capsule Association (Jun-
2008)
• Basic Introduction to Regulatory Affairs – Lyka BDR Pvt Ltd (Sept-2010)
• Induction – Pharmalink Consulting Ltd (Feb 2012)
• Workshop on English Communication skills – Pharmalink Consulting Ltd (Aug-2012)
• Knowledge update sessions for selective markets - Pharmalink Consulting Ltd
• ISO09001:200 Quality Management Systems – Pharmalink Consulting Ltd
• GCMC-EM Systems – Pharmalink Consulting Ltd (Mar-2012)
• GCMC EP – Pharmalink Consulting Ltd (Mar-2012)
• GCMC Ancillary Documents Projects and systems EP – Pharmalink Consulting Ltd (Oct-
2013)
• Electronic format (eCTD) submissions – Pharmalink Consulting Ltd (Dec-2013)
• Seminar on attitude and motivation (by Nirupama Hukku) – Pharmalink Consulting Ltd
(Aug-2013)
• Training on Compliance project – Pharmalink Consulting Ltd (Jan-2014)
• Certification Course of “Global Project Management for Regulatory Affairs” – Genpact
Pharmalink (Jun-2015)
• Lean classroom training – Genpact Pharmalink (May-2015)
• Workshop on Professional Skills Trainings :- People Management; Interpersonal Skills;
Corporate Etiquette – Genpact Pharmalink (Feb-2016)
• Workshop on Professional Skills Trainings :- SEACIP (Skills Enhancements and Corporate
Interface Program) – Genpact Pharmalink (Jul-2016)
• Lean training for Lean Thinkers – Genpact Pharmalink (Dec-2016)
• Green Belt Curriculum (Jan-2017)
PROJECT: (Final Year B. Pharm)
‘Vectors’ in Biotechnology: Genes are inserted into the body using gene carriers called vectors. The most common
vectors now are viruses, which have evolved a way of encapsulating and delivering their genes to human cells in a
pathogenic manner.
OTHER ACTIVITIES / ACHIEVEMENTS:
• Won second prize in Volley Ball-senior team in 10th
Std (2003-2004). Won best player for the game.
• Won the finals of Girls ‘Throw ball’ competition in S.Y.B.Pharm (2007) and T.Y.B.Pharm (2008).
• Won the finals of Girls cricket Intra-College in T.Y.B.Pharm (2008).
• Won Intra college Carom-Doubles competition in S.Y.B.Pharm (2007).
• Won second prize for Chess Intra-college competition in T.Y.B.Pharm (2007).
• Won first prize for Group Dance competition in T.Y.B.Pharm (2008).
• Won the Inter-College “Street Play” competition in S.Y.B.Pharm (2007).
• Participated in Inter campus “Street Play” competition in S.Y.B.Pharm (2007) in Pharmacy week.
• Participated in Inter-college Table Tennis competition in Final Y.B.Pharm (2010).
• Participated for Inter-college Chess competition in T.Y.B.Pharm (2007) and Final Y.B.Pharm (2010).
• Participated in Inter-campus ‘Throw ball’ competition in Final Y.B.Pharm (2010).
• Participated for Inter-college Dance competition in T.Y.B.Pharm (2008) and Final Y.B.Pharm (2010).
• Participated in Inter-college ‘Add Mad Show’ Drama competition in S.Y.B.Pharm (2007).
• Participated in Inter-college Elocution competition on Women rights in S.Y.B.Pharm (2007).
• Actively participated as a volunteer in Health Checkup Camping in Pharmacy week.
• Active part of Event Management Committee for 8 months – Pharmalink Consulting.

4. Curriculum Vitae
RAGINI NIKAM
EDUCATION:
B.Pharmacy graduate (2006-2010) from Sinhgad Institute o f Pharmaceutical Science, Lonawala
MEMBERSHIP:
Registered Pharmacist in Maharashtra State Pharmacy Council, India; with Pharmacist’s Registration Certificate No.
119204 and Date of registration on 09.05.2011 with lifetime validity
PERSONAL DETAILS:
Date of Birth : 23rd
Jan 1988
Place of Birth : Mumbai
Nationality : Indian
Marital Status : Single
Languages Known : Marathi (Mother tongue), Hindi, Gujarati and English
Hobbies : Swimming, Driving, Dancing, Singing, Visiting different places.
Sr. No. Year Standard Percentage University/Board
1. 2003-2004 10th
81% MH board (Mumbai)
2. 2005-2006 12th
74% MH board (Mumbai)
3. 2006-2007 F.Y.B.Pharm 66% Pune University
4. 2007-2008 S.Y.B.Pharm 66.08% Pune University
5. 2008-2009 T.Y.B.Pharm 63% Pune University
6. 2009-2010 Final Year 64% Pune University