1. CURRICULUM VITAE
SATHYASWAROOP ROUT
M. Pharm with 6 years experience in Regulatory Affairs
Flat No. 504, A-Wing, Plot No. 50, Ajinkya Apartment,
Sector-30, Vashi (W), Navi-Mumbai 400705
E-mail: sathyaswaroopr@gmail.com
Phone No. 9730339006, 9545598180
CAREER OBJECTIVE: To attain the heights of professional excellence through continuous learning and
making valuable contribution to the organization.
PROFESSIONAL EXPERIENCE
Organization Designation Duration
Flamingo PharmaceuticalLtd. Sr. Executive-Regulatory Affairs May 2016 till date
ELC Group Sr. Executive-Regulatory Affairs May 2014 to April 2016
Bharat Serums and Vaccines Ltd. Executive-Regulatory Affairs November 2010 to April 2014
Biocon (Clinigene Int. Ltd.) Clinical Research Coordinator June 2010 to November 2010
PRESENT ORGANIZATION
Current Organization: Flamingo Pharmaceutical Limited, Chembur (E), Mumbai
KEY RESPONSIBILITIES
 Leading a team for EU submission activity.
 Preparation and submission of high quality registration dossiers (Module 1 to 3) for pharmaceutical
products to MHRA as per eCTD format via NP.
 Preparation and submission of BROMI application.
 Resolve the RFI raised by regulatory authorities within the given timeframe and submission.
 Life cycle management, hands on experience of EDUCE's - Dossier management tool for eCTD.
PREVIOUS ORGANIZATION
Previous Organization: ELC Group, Chembur (E), Mumbai
KEY RESPONSIBILITIES
EU submission activity:
 Preparation of registration dossiers for solids, parenterals and biologics for EU market.
 Responsible for providing technical Ad-Hoc advice for different queries related to regulatory
submission, global submission strategy planning including EU for the clients coming first time for
Europe market.
 Preparation and submission of high quality registration dossiers (Module 1 to 3) for pharmaceutical
products as per current EU legislation and regulatory requirement for submission in EU via CP/
DCP/MRP/NP as per eCTD format.
 Life Cycle management (variations, renewals and PSUR filing in eCTD / NeeS format) for various
pharma products registered in EU countries.
 Technical review and preparation of Gap analysis of dossier, variation package to make it up-to-date
as per the EU regulations.
 Preparation and submission of safety signal assessment to PRAC, article 61(3) notification packages
& MA transfers.
 Anticipate and resolve the queries raised by regulatory authorities within the given timeframe and
updating the submission checklists.
 Addressing and discussing significant deficiencies with ex-agency experts, client’s QA, R&D
departments, business development for developing dossier related documentations and RA relevant
activities.
 Preparation and submission of application form and briefing documents for Scientific Advice
meeting to MHRA-UK, MPA-Sweden, MEB-The Netherlands.

2.  eCTD/NeeS submission activities: pdf documents creation, bookmarking, hyperlinking, property
setting, publishing and validating using e-Validators.
US submission activity:
 Preparation of US MA transfer application and eCTD publishing.
PREVIOUS ORGANIZATION
Previous Organization: Bharat Serums and Vaccines Limited, Thane, Mumbai
KEY RESPONSIBILITIES
 Handling Parenteral products: Biotech products (recombinant-monoclonal & polyclonal), Biologics
(hormonal products, equine and blood products), Antibiotics and Anticancers.
 Compilation of registration Dossier as per CTD & ACTD format for submission to various regulatory
agencies as per agreed timelines.
 Submission of Re-registration dossiers and variations to various regulatory agencies.
 Preparation of DMF as per ICH guideline.
 Compilation of response to Deficiencies.
 Archival and maintenance of status on availability of approval letters (Marketing Authorization /
Trade Mark approval certificates).
 Review of labeling with respect to regulatory requirements
 Direct Coordination with International Clients for Registration objective viz., CIS (Russia, Ukraine)
Asian (Vietnam, Malaysia) and African countries (Kenya, Nigeria, Zimbabwe, Uganda, Ivory Coast)
 Request and collation of the Exhibit batch documentation from the various departments (QA, QC
and R&D)
 Participated in regulatory bodies audits (PICS, IRAN, PPB-Kenya, INVIMA-Colombia, Jordan)
 Filing various biosimilar application to DCGI (Form-44, Form-40, Form-10 & Form-11)
Filing of Registration Dossier for following Markets
 CIS - Russia, Ukraine, Kazakhstan
 Africa–Kenya, Nigeria, Zimbabwe, Togo, Burkina Faso, Ivory Coast, Rwanda, Morocco
 Latin America – Costa Rica, Bolivia, Peru, Dominican Republic.
 Asia – Vietnam, Malaysia, Thailand, Pakistan, Sri Lanka
 Middle East –Syria, Iran, Iraq
PREVIOUS ORGANIZATION
 Previous Organization: Biocon (Clinigene Int. Limited), Bangalore
JOB RESPONSIBILITIES
 Submitting regulatory documents to IRB and Sponsor
 Drive patient recruitment & a part of ICF process.
 Electronic capturing of data (EDC) from CRF.
 Clinical on-site monitoring activities
 CRF verification against Source data.
 IP accountability
 Participate in the internal and sponsor audit.
 Preparing for study closure and archiving
o Documenting an adverse event, including(describing the event, severity and frequency,
treatment, resolution)
 Maintaining communication and correspondence with subjects, sponsor, monitor and other site
study personnel.
TECHNICAL EXPERIENCE
 Trained in eCTD publishing for US submission
 Guidelines and Regulations of ICH and different regulatory bodies
 Pharmacovigilance Guidelines
 Strong domain knowledge in the field of Clinical Trials

3. EDUCATION
 M. Pharm (Pharmacology) from SPS under SOAU (Odisha) in 2010 with CGPA-9.02
 B. Pharm from Sri Jayadev College of Pharmaceutical Sciences under BPUT(Orissa) in 2008 with
CGPA-8.08
 Advance Diploma in Clinical Research and Pharmacovigilance from Syncorp Clincare Technologies,
Bangalore in 2010.
 Diploma in business management (International Marketing) from IGNOU, Mumbai.
PROJECT HANDLED
 M. Pharm Project: “Effect of Etoricoxib on incidence of Azoxymethane induced colorectal cancer”.
 B. Pharm Project: “Retrospective evaluation of diabetes”.
ACHIEVEMENT
 Selected by Indian Council of Medical Research (ICMR) to attend a workshop on “Modular course
on Pharmacovigilance” on the basis of project submission with titled “Risk management plan for
recombinant human follicle stimulating hormone used in subjects undergoing in-vitro
fertilization” sponsored by Bharat Serums and Vaccines Limited.
 Presenting my college to an AICTE sponsored National seminar on PHARMACEUTICAL
NANOTECHNOLOGY at Pusad, Maharashtra. Poster - “Antiasthmatic effect of a Homeopathic
formulation”.
 Presenting a scientific poster at Royal college of Pharmacy and health sciences, Berhampur, Orissa,
organized by Orissa Pharmaceutical association with the theme “Current trends in Pharmaceutical
education and Research”. Poster – Biomarkers in Drug development
 Awarded with Man of the Series in BSV Group Cricket Tournament held on 26th April, 2013
SOFT SKILLS
Operating Systems Window XP/Vista/Window 7/Window 8, 8.1, 10
Productivity Tools MS Office (MS Word, MS PowerPoint, MS Excel), PDF
PERSONAL INFORMATION
Father’s Name : Mr. Harish Ch. Rout
Mother’s Name : Smt. Nirupama Rout
Date of Birth : 04th July 1985
Sex : Male
Marital Status : Married
Nationality : Indian
Religion : Hinduism
Language known: English, Hindi, Odia & Marathi
Strengths : Good communication skills, Good Team Player, Willingness to learn, High degree of self-
motivation, Hardworking, Honest, Leadership, Punctuality.
REFERENCES
Sanjeeb Mishra
Head-QA, Bharat Serums and Vaccines Ltd.
Mob: 09850047645
E-mail: skmishra321@rediffmail.com
Dr. Pratap Kumar Sahu
Dy. Dean, SOA University, Bhubaneswar
Mob:09437035910, 09437389256
E-mail:pratap.sps@soauniversity.ac.in
DECLARATION
I hereby declare that all the information stated above is true to the best of my knowledge and I take the
sole responsibility of its correctness.
Place: Mumbai (SathyaswaroopRout)