1. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 1 of 8
Objective
A Ph.D. chemist seeking a challenging leadership position that will allow me to utilize my knowledge, scientific and
regulatory experience as a VP, Regulatory Affairs, Team Leader in Office of Generic Drugs in CDER/FDA,
Principal Consultant at Parexel International and Senior Scientist at National Cancer Institute,
Professional Summary
 More than 15 years of experience in FDA and othergovernment agencies, evaluating the chemistry,
manufacturing, and control (CMC) sections of applications and performing scientific research
 Experienced in the assessment, reviewing and writing of ANDAs and NDAs with a focus on 505(b)(2) NDAs,
IND), DMFs, and FDA briefing documents for diverse therapeutic classes of drugs
 Worked with a broad range of dosage forms and drug products including anti-diabetics, anti-epileptics, anti-
Alzheimer’s, oncologic, topical antibiotics, NSAIDs, cardiovascular drugs, , PDE-5 Inhibitors, narcotic
analgesics,iron-carbohydrate products,to name a few
 Instrumental in establishing a DMF review division in FDA to meet the GDUFA (generic drug user fee act)
related goals;
 Pivotal role in writing of the Draft Guidance for Industry:Initial Completeness Assessments forType II API
DMFs Under GDUFA, which is currently being used by FDA to assess the “completeness” of Type II DMFs
under GDUFA and a QbR for Drug MasterFiles, including a companion document, which is soon to be adapted
by CDER for DMF review
 Presented the initiative related to DMFs at several national and international industry forums as well as within
FDA
 Actively participated in writing the QbR for ANDAs, presented the Office of Generic Drug’s Question based
Review (QbR), Quality by Design (QbD) initiative to the industry forums and international forums
 Primary author of the fist draft of QbR for APIs, which is soon to be finalized for Type II DMFs as well as 3.2.S
section of NDA submissions
 Well known for a series of articles regarding the common deficiencies in ANDAs, which have been translated
to many languages and have streamlined the review process within the agency and helped the industry,by
providing transparency and clarity regarding the agency’s rationale behind citing deficiencies
 Member and FDA Liaison of Monograph Development Committee of USP for Cardiovascular Drugs 2005-
2010 and USP Excipient committee from 2010-2012.
 Participated in working groups,committees, and preparation of guidance documents, including working with
the CDER Tiger Team to meet the GDUFA goals for CMC reviews in CDER/FDA.
 Received special citation from CDER Office Director for leadership in implementing and developing innovative
DMF review systemin OGD
 Research focus at National Cancer Institute on anti-cancer small molecules, that are potential nitric oxide
donors
 Published many scientific and regulatory articles in peer reviewed journals
Work Experience
June 2016-Present Lupin Inc., Baltimore
Vice President, Regulatory Affairs
The position involves championing regulatory efforts for the generic and specialty business based on extensive
experience and in-depth knowledge of US regulatory requirements; possess working knowledge of submission of

2. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 2 of 8
biosimilars; working in a matrix organization on a multinational basis; designing and developing processes which
would ensure that every product meets federal regulatory requirements.
Responsibility involves the following:
 Overview of all submissions, approvals, and maintenance including development of regulatory strategies
for high barrier generics and improved branded versions of approved molecules.
 Communicate effectively within the organization and with internal/external customers regarding product
related activities.
 Work very closely with the R&D to provide early guidance/support to ensure the completeness of filing and
facilitate the ease of review at the FDA.
 A high level interaction with all key team leads of other departments to ensure the transparency of FDA
communications.
 Extensive interaction with the OGD and New Drug Divisions of the FDA.
 Lead and develop Regulatory Department direct reports.
 Support with biosimilar filings
 Supporting with products requiring clinical studies – NDA’s including 505b2 pathways, as well as
ANDA’s (ie, topical products).
June 2012 – June 2016 PAREXEL International
Principal Consultant
Provide strategic guidance to applicants in the area of regulatory and chemistry, manufacturing and controls for drug
products and drug substancesat all stages ofdevelopment and for all types of regulatory submissions, NDAs, INDs,
ANDAs, DMFs, including Quality-by-Design (QbD) submissions.
Supporting several 505(b)(2) NDAs and complex generic applications at US FDA
 Act as thought leader in in various scientific and regulatory aspects related to drug development and
manufacturing.
 Work in a high volume, fast paced environment at with changing deadlines and priorities
 Collaborate in projects with diverse group of scientific experts and regulators
 Provide advice and strategies for regulatory submissions with the goal of anticipating regulatory
challenges with an optimal business process that leverages PAREXEL’s multidisciplinary expertise.
 Present on behalf of the industry in many national and international forums
November 2011-June 2012 Office of Generic Drugs, FDA
Team Leader/DMF Pilot Team
 Responsible for establishing a new division within CDER for review of Type II Drug Masterfiles
 Planning and establishing program goals and objectives for the future division, laying the outline of
workflow, staffing requirements etc.
 Developed the matrices for the productivity of the division since this is the first time a Drug MasterFile
review division is being established at FDA
 Establishing lines of communication between Office of Generic Drugs and other offices (ONDQA, CVM,
OBPM) who are also involved with DMFs
 Writing Internal Quality Procedures (OPS equivalent of SOPs) for DMF review

3. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 3 of 8
 Developing a training program for the new reviewers who may join the division in near future
 Laying the groundwork for developing guidances and also documents related to Question Based Review of
Drug MasterFiles
 Providing valuable input in improving the submissions of Drug Master Files as a member of the Drug
MasterFile Guidance group in Office of Pharmaceutical Sciences/FDA
 Providing input as a team leader to the OGD Quality by Design initiative for the generic drugs
 Writing the first draft for a Question Based Review (QbR) for APIs, which is currently being finalized and
will be adopted for generic as well as new drugs
 Performing secondary and tertiary review of Drug MasterFiles
March 2008-November 2011 Office of Generic Drugs, FDA
Team Leader/Division III
 Performing secondary reviews of abbreviated new drug applications
 Responsible for establishing program goals and objectives for the team
 Researching of ANDA and DMF related problems, consulting with other professionals both within and
outside the Division, and otherFederal Agencies as needed
 Counseling and training team members, personally explaining critical and significant scientific concepts,
establishing processes,procedures,and guidelines
 Addressing professionalgroups in the areas that affect the mission of the Office of Generic Drugs
 Published and presented on several occasions regarding FDA perspective of the current state of Question
Based Review- Quality overall summary
 Published a series of articles regarding the common deficiencies in ANDA to streamline the review process
within the agency and also help the industry by providing transparency and clarity regarding the agency’s
rationale behind citing deficiencies. This series has been translated to many languages.It is currently part
of the reviewer training manual of OGD. Also,GPhaA published a white paper on “Enhancing ANDA
Submissions: Working towards First Cycle Approval” in 2014, based on this series.
 Presented to Generic Pharmaceutical Association (GPhA) on behalf of FDA.
 One of the main Presented the Office of Generic Drug’s Quality by Design initiative at several Industry
forums and also international forums
 Communicating with several offices within the FDA to make recommendations regarding drug shortage,
citizen petitions and also otherissues regarding pharmaceuticals
August 2003-March 2008 Office of Generic Drugs, FDA
SeniorReviewer in Division I and Division III
 Responsible for review and evaluation of the Chemistry and Manufacturing Controls Section of Abbreviated
New Drug Applications and CMC Post ApprovalChanges
 Participated and led internal meetings with an interdisciplinary review team to assess the safety and efficacy of
generic drugs
 Presented in several national and international meetings
 Participated in CDER activities such as seminars, courses,workshops on regulatory issues
 Member of USP Expert Committee for Cardiovascular Drugs
 Member of the Excipient Working Group at the Office of Generic Drugs, FDA
 Member of the Question Based Review Working Group at the Office of Generic Drugs, FDA
 Participated in writing a sample QbR-QOS for modified release tablets, which is posted in the FDA website
 Reviewer of the first application submitted in QbR-QOS format
January 2001-June 2003 National Cancer Institute, Frederick, MD

4. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 4 of 8
SeniorStaff Scientist Advisor: Dr. Larry K. Keefer
 Studying the metabolites formed by NO donor prodrugs in vitro on incubation with various isoforms of
cytochrome P450, with special interest in CYP3A4, 1A1 and CYP2E1
 Designing and creating a dynamic website, with an extensive database ofnitric oxide donors made by our
group, the address of the site is http://home.ncifcrf.gov/lcc/nitricoxide/default.asp
December 1994-December 1998 National Cancer Institute, Frederick, MD
Intramural Research Fellow Advisor: Dr. Larry K. Keefer
 Worked with a novel class of nitric oxide donors pro-drugs
 Elucidated the photochemistry of a class of drugs designed for topical application
 Provided analytical support for in vitro and in vivo studies of the fate of the nitric oxide donors
 Successfully developed of a class of nitric oxide donors that are selectively activated in drug resistant tumors
 Participated in designing a class of nitric oxide donors that may be possible treatment for sickle cell anemia
 Modified various analytical methods of measuring the extent of nitric oxide released in vivo by nitric oxide
donors
June 1993-August 1994 University of Missouri, Columbia
Research Associate Fellow Advisor: Dr. Milton Feather
 Did research in the field of carbohydrate chemistry. Developed a stereospecific total synthesis ofuniformly 14C
labeled l-ascorbic acid starting from uniformly 14C labeled d-glucose by modifying the method of Theander et
al.
May 1988-June 1993 University of Missouri, Columbia
Graduate Research Assistant Advisor: Dr. Richard N. Loeppky
Investigated the mechanism of activation of -hydroxynitrosamines, a potent class of animal carcinogens
 Synthesized possible intermediates in the carcinogenic activity of these nitrosamines, and studied their reaction
with cellular reducing agents
 Elucidated the mechanism of nitrosamine activation by identifying and carefully quantifying the products
formed in the reaction, trapping reactive intermediates in situ and performing a detailed kinetic study
 Studied the mechanism of nitrosation of N-substituted aziridines, leading to the synthesis and identification of a
new class of four membered ring compounds,the dihydrodiazete-N-oxides
Education
The University of Missouri at Columbia
PhD in Chemistry, 1993
GPA: 4.0/4.0
Thesis: A study of putative intermediates involved in the activation of -oxidized nitrosamines and nitrosation of N-
substituted aziridines
Calcutta University, India
Masterof Science in Chemistry, 1987
Grade: First Class, Top 1% of the University
Presidency College, Calcutta University, India
Bachelor of Science in Chemistry, 1985
Grade: First Class with Honors, Top 1%

5. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 5 of 8
South Point High School, Calcutta, India
Graduated in 1981
Grade: First Division with Star, Top 1% of the State
Honors
 Center Director’s Special Citation 2011,CDER/FDA (for leadership in implementing and developing the
innovative DMF Review System in OGD)
 NIH Intramural Research Training Award, National Institutes of Health (grant award for research in the field
of nitric oxide)
 Team Excellence Award, FDA (leadership for review of bolus application of generic Zonisamide in record
time)
 Team Excellence Award, FDA (for review of first ANDA under OGD QbR initiative)
 Team Excellence Award, FDA (for exceptional performance in preparing example Quality Overall Summaries
to guide sponsors and reviewers in implementation of OGD’s Question-based Review
 Dedicated Volunteer Service Recognition, USP (for contribution as a member of USP Expert Committee for
Cardiovascular Drugs)
Patents
 Saavedra, J. E., Keefer, L. K., Srinivasan, A., Rice, W. G., Ji, X., and Bogdan, C.: O2-Arylated or O2-
glycosylated 1-substituted diazen-1-ium-1,2-diolates and O2-substituted 1-[2-(carboxylato)pyrrolidin-1-
yl]diazen-1-ium-1,2-diolates. U.S. Patent 6,610,660, August 26, 2003.
 Saavedra, J. E., Keefer, L. K., Srinivasan, A., Bogdan, C., Rice, W. G., and Ji, X.: O2-glycosylated 1-
substituted diazen-1-ium-1, 2-diolates. U.S. Patent 6,911,433, June 28, 2005 (continuation in part of U.S.
Patent 6,610,660).
Publications
Aloka Srinivasan, White Paper – Complex Generics: Maximizing FDA Approval ProcessAloka Srinivasan;
https://www.parexel.com/files/6714/3076/9385/ComplexGenerics_WPApril2015_final.pdf.
Aloka Srinivasan, Excipients in Generic Formulations, April1, 2014, Pharmaceutical Technology, Solid Dosage and
Excipients e-book, http://www.nxtbook.com/nxtbooks/ptebooks/pt_ebook_201404/index.php
A. Srinivasan; Q&A on GDUFA implementation with Aloka Srinivasan, Sep 2, 2012, Pharmaceutical Technology,
Volume 36, Issue 9, pp. 22-24
Debra; Torres de Holding, Claudia; Thomas, Lynta; Peterson, Kyle; Goodman, Gens; Saavedra, Joseph; Srinivasan,
Aloka; Davies, Keith; Keefer, Larry; Miranda, Katrina; HNO and NO release from a primary amine-based
diazeniumdiolate as a function of pH. Inorganic Chemistry. 2011, 50(8), pp. 3262-70
A. Srinivasan, R. Iser; Common Deficiencies in Abbreviated New Drug Applications Part 4: Control of the Drug
Product and Stability, Pharmaceutical Technology,April 2, 2011, 35 (4), pp. 62-68
A. Srinivasan, R. Iser and D. Gill; Common Deficiencies in Abbreviated New Drug Applications Part 3: Control of
the Drug Product and Stability, Pharmaceutical Technology,February 2, 2011, 35 (2), pp. 58-67
Aloka Srinivasan and Robert Iser, Devinder S. Gill; Common Deficiencies in Abbreviated New Drug Applications

6. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 6 of 8
Part 2: Description, Composition and Excipients, Pharmaceutical Technology,August 2, 2010, Volume 34 (8), 45-
51
Aloka Srinivasan and Robert Iser; Common Deficiencies in Abbreviated New Drug Applications
Part 1: Drug Substance, Pharmaceutical Technology,January 2, 2010, Volume 34 (1), pp. 50-59
Aloka Srinivasan and Robert Iser, FDA Office of Generic Drugs Question-Based Review Initiative:
An Update—Past,Present, and Next Steps, Journal of Validation Technology,Volume 15 (2), 2009, 2-5
Salmon, Debra, Torres de Holding, Claudia, Thomas, Lynta, Peterson,Kyle, Goodman, Gens, Saavedra, Joseph,
Srinivasan, Aloka, Davies, Keith, Keefer, Larry,Miranda, Katrina; HNO and NO release from a primary amine-
based diazeniumdiolate as a function of pH, Inorganic Chemistry, in press,Manuscript ID ic-2010-01736e.R1
X. Ji, A. Patel, R. Kalakathur, X. Hu, Y. Gu, J. E. Saavedra, G. S. Buzard, A. Srinivasan, L.K. Keefer, S. V. Singh;
Structure based design of anticancer drug, PABA/NO, Drug Design, Development and Therapy, 2008: 2, 123-130.
Larry K. Keefer, Keiko Inami, Raymond W. Nims, Aloka Srinivasan, et. al; V-PYRRO/NO, by human microsomal
cytochromes P450 Nitric Oxide: Biology and Chemistry, 2006, 14 (4), 309-15
Joseph E. Saavedra, Aloka Srinivasan, Larry K. Keefer, et. al: PABA/NO as an Anticancer Lead: Analogue
Synthesis,Structure Revision, Solution Chemistry, Reactivity toward Glutathione, and in vitro activity
J. Med. Chem.; 49 (3), 1157-64, 2006
Srinivasan, A., Kebede, N., Saavedra, J. E., Nikolaitchik, A. V., Brady, D. A., Yourd, E., Davies, K. M., Keefer, L.
K., and Toscano,J. P.: Chemistry of the diazeniumdiolates. 3. Photoreactivity. J. Am. Chem. Soc.123:5465-5472,
2001.
Saavedra, J. E., Srinivasan A., Bonifant, C. L., Chu, J., Shanklin, A. P., Flippen-Anderson, J. L., Rice, W. G.,
Turpin, J. A., Davies, K. M., and Keefer, L. K.: The secondary amine/nitric oxide complex ion R2N[N(O)NO]- as
nucleophile and leaving group in SNAr reactions. J. Org. Chem. 66: 3090-3098, 2001.
Southan,G. J., and Srinivasan, A.: Nitrogen oxides and hydroxyguanidines : Formation of donors of nitric and
nitrous oxides and possible relevance to nitrous oxide formation by nitric oxide synthase. Nitric Oxide:Biology and
Chem. 2: 270-286, 1998.
Hrabie, J. A., Srinivasan, A., George C., and Keefer, L. K.: Reaction of nitric oxide with the imine double bond of
certain Schiff bases. Tetrahedron Lett. 39: 5933-5936, 1998.
Southan,G. J., Srinivasan, A., George, C., Fales, H. M., and Keefer, L. K.: N-Nitrosated N-hydroxyguanidines are
nitric oxide-releasing diazeniumdiolates. Chem. Commun. 1191-1192, 1998.
Kelman, D. J., Christodoulou, D., Wink, D. A., Keefer, L. K., Srinivasan, A., and Dipple, A.: Relative
mutagenicities of gaseous nitrogen oxides in the supF gene of pSP189. Carcinogenesis 18: 1045-1048, 1997.
Loeppky, R. N., and Srinivasan, A.: Thiol oxidation by 1,2,3-oxadiazolinium ions, presumed carcinogens. Chem.
Res. Toxicol. 8: 817-820, 1995.
Loeppky, R. N., Erb, E., Srinivasan, A., and Yu, L.: Chemistry of putative intermediates in the bioactivation of -
oxidized nitrosamines. In Loeppky, R. N. and Michejda, C. J. (Eds.): Nitrosamines and Related N-Nitroso

7. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 7 of 8
Compounds,Chemistry and Biochemistry. Washington,D.C., American Chemical Society (ACS Symposium Series
No. 553), 1994, pp. 334-336.
Loeppky, R. N., Srinivasan, A., and Erb, E.: Putative proximate carcinogens derived from ethanolnitrosamines:
Chemical properties. In O'Neill, I. K. and Bartsch, H. (Eds.): Nitroso Compounds: Biological Mechanisms,
Exposures and Cancer Etiology. Lyon, International Agency for Research on Cancer (IARC Technical Report No.
11), 1991, pp. 42-43.
Loeppky, R. N., Qing F., Srinivasan, A., Glaser, R., Barnes, C. L., and Sharp, P. R.: Nitrosoaziridinium ion
isomerization: dihydrodiazete-N-oxides and azoxyalkenes from aziridine nitrosation. J. Am. Chem. Soc. 113: 2308-
2309, 1991.
Presentations
Srinivasan, Aloka: Proper CMC Submissions: Drug Substance:Defining Regulatory Starting Materials, GPhA CMC
Workshop,Bethesda, MD, June 9-10, 2015
Srinivasan, Aloka: Recent API-related FDA’s Question-based Review for APIs in Applications for new drugs and
generics, 17th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Vienna, Austria,
November 5–7, 2014
Srinivasan, Aloka: Proper CMC Submissions: Industry Perspective –API, GPhA CMC Workshop,Bethesda, MD,
June 3-4, 2014
Srinivasan, Aloka: Recent API-related Developments at FDA’s Office of Generic Drugs: GDUFA & Question-
Based Review, 15th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Budapest,Hungary,
November 07, 2012 – November 09, 2012
Srinivasan Aloka; Drug Substance Review, GPhA Fall Technical Conference, 2011, Bethesda, MD, October 3-5,
2011
Srinivasan Aloka and Iser, Robert: QbR Lessons Learned & Common Deficiencies in Abbreviated New Drug
Applications, GPhA Fall Technical Conference, 2010, Bethesda, MD, October 19-21, 2010
Srinivasan, Aloka, Iser, Robert and Lostrito, Richard: Signature Series: Deficiencies in New Drug Applicatoins,
Interphex Annual Conference, 2010, New York, NY, April 21, 2010
Srinivasan, Aloka and Iser, Robert, Key note address:FDA’s Quality-by- Design Program for Generic Drugs,
Pharmaceutical Tecnology’s 3rd AnnualConference, Philadelphia, PA, August 12, 2009
Srinivasan A: Review of the First ANDA with QbR-QoS: Lessons Learnt; Office of Generic Drugs, Rockville, MD,
July 12, 2006
Srinivasan A: Question-based Review for Quality Assessment of Generic Drugs; GPhA ANDA Basics Course,
Rockville, MD, May 25, 2006
Srinivasan A: Review of Amendments: Second Cycle and Beyond; Office of Generic Drugs Retreat, Gaithersberg,
MD, Sept 7, 2005
Srinivasan A: O2
-Substituted Diazeniumdiolates: A Novel Class of Nitric Oxide Donors; Office of Generic Drugs,
Rockville, MD, March 2004

8. Aloka Srinivasan
3280 Kinross Circle
Herndon, VA 20171
Phone: 703-736-0555
Email: srinin@aol.com
Page 8 of 8
Srinivasan, A: Chemistry of the Diazeniumdiolates. RHN[N(O)NO]- Ions as Progenitors of Both Nitroxyl and Nitric
Oxide: 228th National ACS Meeting, Philadelphia, PA, 2004
Srinivasan, A.: O2-Substituted diazeniumdiolates as nitric oxide donors.Invited talk, Glaxo-SmithKline, King Of
Prussia, PA, 2001
Srinivasan, A.: Diazeniumdiolates: A new class of nitric oxide donors.Invited talk, Parke Davis, Ann Arbor, MI,
1999
Srinivasan, A.: Chemistry of O2-substituted diazeniumdiolates. Invited talk, ABC Laboratories, Columbia, MO,
1999
Srinivasan, A., Saavedra, J. E., Booth, M., and Keefer, L. K.: O2-Aryl diazen-1-ium-1,2-diolates as nitric oxide
releasing agents. 213th National ACS Meeting, San Francisco, CA, 1997
Srinivasan, A., Saavedra, J. E., and Keefer, L. K.: Photolysis of O2-alkyl diazeniumdiolates: Are they photo
chemically triggered nitric oxide donors? 211th National ACS Meeting, New Orleans, LA, 1996
Srinivasan, A.: The chemistry of putative intermediates in the activation of beta-oxidized nitrosamines and
nitrosoaziridines. American Health Foundation,Valhalla, NY, 1993
Loeppky, R. N., Erb, E., Srinivasan, A., and Yu, L.: The chemistry of putative intermediates in the bioactivation of
beta-oxidized nitrosamines. 204th National ACS Meeting, Washington,DC, 1992
Srinivasan, A., Loeppky, R. N., Feng, Q., Glaser, R., Barnes, C. L., and Sharp, R. P.: Diazete-N-oxides and
azoxyalkenes from aziridine nitrosation. 203rd National ACS Meeting, Boston, MA, 1991
Srinivasan, A., Loeppky, R. N., Glaser, R., Barnes, C. L., and Sharp, P. R.: Aziridine nitrosation - a theoretical and
experimental study. Midwest Regional ACS Meeting, Manhattan,KS, 1990
Lahiri*, A. and Loeppky, R. N.: Thiol oxidation by alkoxydiazenium and 3-alkyl-1,2,3-oxidiazolinium ions.
Midwest Regional ACS Meeting, St. Louis, MO, 1989
*currently Srinivasan
Interviews
Backlog Backfire: FDA Sees Increase in Pending Generic Applications At Deadline, By Derrick Gingery, Pink
Sheet, Volume 74, No. 42, 2012
FDA's Dr. Srinivasan Discusses Question-based Reviews and QbD for Generic Drugs, By: Angie Drakulich, Jul 23,
2009, ePT--the Electronic Newsletter of Pharmaceutical Technology
References
Available upon request