1. Career Objective
I aim to be part of a dynamic team looking after the regulatory affairs which encourage
and give me an opportunity to use my technical and regulatory skills to make the
regulatory process, for marketing authorization of the drug product, more productive
and also give me a chance to grow professionally.
Work Experience
 Total Experience: 3 years 10 months extensive experience in regulatory affairs work
environments (USFDA, Brtazil and China).
July’2012 to till date: I am working as a Research Associate-IV at Aurobindo Pharma Limited
in the department of Regulatory Affairs [Regulated Markets (i.e. USA, Brazil, and China) for
Solid orals and liquid oral dosage forms].
Role and responsibilities at Aurobindo Pharma Ltd.:
US-FDA:
 ANDA Compilation and Submission to USFDA.
 Responding to Queries recived for ANDAs and responses submission to USFDA.
 Preparation and submission of Amendments, Supplements and Annual Reports for
Tentatively approved products/approved products (Post approval activities).
 Co-ordination with various departments for receipt of technical documents and to review the
same to assure for compliance to FDA regulatory requirements.
 I have a sound Knowlrdge on the technical documents such as
• Specifications & Standard Test Methods{STP} (For API & Finished dosage form [Solid
orals i.e. Tablets and Capsules and oral liquids])
• Batch Manufacturing records and Packaging records.
• Certificate of Analysis (COA) and respective chromatograms.
Name : Sravan Bandi
Address : Plot #34/A,
Jayalakshminagar,
R.C. Puram,Hyderabad,
Telangana, India.
Mobile : +919866477511
Email : Sravanbandi140@gmail.com
Regulatory Affairs Specialist
[3 yrs 10 months of Experience in US
FDA and Brazil ANVISA]

2. • Method validation Protocol and Reports.
• Method Equivalence Reports .
• Stability Protocol & Stability data.
• Pharmaceutical development report.
• Inactive ingredients Specs, COA, STP and Declarations.
• API DMF related documents.(LOA, cGMP, API-Open part of CTD and Declarations)
• Packaging material Specifications, safety certificates, DMF LOA, Certificate of Analysis
and Drawings.
 Review of final compiled CTD dossier for further E-submission to US FDA.
 Acquiring knowledge upon day to day US FDA updations.
Brazil-ANVISA:
 Preparation & Compilation of ANVISA DOSSIER for submission to BRAZIL.
 Review of final compiled dossier for further submission to regulatory agency.
 Respond the country specific queries/requirements received from respective affiliates.
 Taking care of regulatory post approval activities.(i.e, Annual product reviews)
 Responding to Deficiencies received from customers and regulatory authorities.
 Review of the technical documents for further complitaion.
 Preparation & Submission of Certificate of Pharmaceutical Product to ANVISA (Brazil).
China-CFDA:
 Compilation of the dossier in CTD format for CHINA (C-FDA). Preparation &
Submission of Certificate of Pharmaceutical Product and application forms to CFDA (China).
Responding to Deficiencies received from customers and regulatory authorities.
Miscellaneous:
 Preparation & Submission of Certificate of Pharmaceutical Product and application forms
to MFDS(South Korea). Maintaining the registration certificates for China, Brazil and Korea.
 Acquiring samples from the plant and send for dissolution analysis & Bio study for
Brazil, China & Korea.
 Dispatching documents and samples to respective countries upon request.
 Overview knowledge on the EU CTD Formats.
 High skills in maintaining professional relationships with all levels of staff.
 Outstanding analytical and problem-solving abilities.

3. Education
PERSONAL PROFILE
DECLARATION
Degree University/ Board Institute / School Percentage
Master of
Pharmacy
(Pharmaceutics)
JNTU-HYDERABAD UNITY College Of Pharmacy. 82 %
Bachelor of
Pharmacy
Kakatiya University
St. John college of pharmacy,
Warangal.
74.9 %
Intermediate
(2 years Education)
Board of Intermediate of
Andhra Pradesh
Nalanda Junior college,
Guntur.
90.7 %
School of
scoundary
Education
(10 th class)
Board of Secondary
School of Education
Orugallu high school,
Warangal.
86 %
 I qualified in Graduate Pharmacy Aptitude Test-2011 with All India six thousand rank.
 I qualified in Post Graduate Common Entrance Test with rank 1900.
 I worked as Chemistry Lecturer in Venkatreddy Junior College, Hanamkonda for the
2011 Academic year.
Name Sravan.Bandi
Father’s Name Venkataramanarasaiah (late)
Mother’s Name Swaroopa
Nationality Indian
Sex Male
Date of Birth 17th
May 1990
Marital Status Single
Languages Known English, Telugu, Hindi
Hobbies
Browsing, Dancing, learning new things,
seminar presentations, Reading books,
drawing, listening to Music.
I Hereby declare that the above mentioned information is true and to the best of my knowledge.
Sravan Bandi
Place: Hyderabad
REFERENCIAS PERSONALESFORMACIONES ADICIONALES E INTERESES