Sathyaswaroop Rout has over 6 years of experience in regulatory affairs. He currently works as a senior executive of regulatory affairs at Flamingo Pharmaceuticals in Mumbai. Prior to this, he held similar roles at ELC Group and Bharat Serums and Vaccines. His responsibilities include preparing and submitting dossiers for drug registrations in Europe and other markets. He has a M.Pharm degree in pharmacology and additional training in clinical research and pharmacovigilance.

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)