Manager Development
Resume:
DILIP KAUL, M. Pharm., M.S.
Home Address: Office Address:
Hillsborough, NJ 08844 440 Route 22 East, Suite #140
Phone: 908-***-**** (Cell) Bridgewater, NJ 08807
Email: *********@***.*** Phone: 908-***-****
Email: *****.****@********.***
CAREER HIGHLIGHTS
Dedicated and result-oriented professional with more than 20 years of experience
involving all aspects of drug product and medical device development in reputed
multinational pharmaceutical companies with increasing responsibilities
Provided regulatory direction on projects including, but not limited to, general regulatory
strategies, regulatory requirements for medical devices/drug products and marketing
approval in domestic and international markets
Maintained awareness of global regulatory environment for device & drug product
classification and reporting, and assessed impact of changes on business and product
development programs. Facilitated policy and development of standard interpretation of
global regulation
Liaised and negotiated with global regulatory authorities as needed for all aspects
pertaining to the development and marketing of the device and drug product, including
resolution of key regulatory issues to expedite approvals of product and labeling changes
Proactively managed critical issues, taking leadership for the regulatory contribution
Experience in providing regulatory strategy to resolve complex CMC issues
Performed Gap Analysis of CMC sections and recommended strategies to address gaps
Extensive pharmaceutical industry experience with unique combination of regulatory,
stability, compliance, analytical and pharmaceutical development areas
A strong understanding of Drug Substance and Drug Product development process
including clinical design, chemical development and formulation development
Authoring and reviewing eCTD sections of Modules 2 & 3 including Gap Analysis
Proficiency in Documentum, GRESDA, DOMASYS, PREDICT, CoreWMA,
Trackwise, MS-Office
1996 Abbott Laboratories Chairman Award
PROFESSIONAL EXPERIENCE
Therakos Bridgewater, NJ Nov. 2013- Present
Regulatory Affairs Manager
Provided regulatory direction on projects including, but not limited to, general
regulatory strategies, regulatory requirements for medical devices/drug products
and marketing approval in domestic and international markets
Managed regulatory activities for Therakos products including submissions to
FDA and other global regulatory authorities
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DILIP KAUL, M. Pharm., M.S.
Evaluated regulatory issues and provide strategic input and timely
recommendations and alternatives as needed to project teams and management
Provided regulatory guidance and direction to R&D, Quality Affairs, and Clinical
and Medical Affairs related to requirements of device & development activities
globally
Partnered with cross functional teams, specifically Operations, Quality and R&D,
by providing regulatory guidance and support to product development teams for
strategic planning, design, development and risk assessments
Maintained awareness of global regulatory environment for device & drug
product classification and reporting, and assesses impact of changes on business
and product development programs. Facilitate policy and development of standard
interpretation of global regulation
Used extensive knowledge of US, EU and ICH requirements to support
developmental and marketed products to achieve corporate goals
Oversaw the preparation and submission of documentation to support
investigational and marketing registration packages throughout the world and
ensures timelines are met
Liaised and negotiated with global regulatory authorities as needed for all aspects
pertaining to the development and marketing of the device and drug product,
including resolution of key regulatory issues to expedite approvals of product and
labeling changes
Built partnerships with stakeholders from other functions to ensure that strategic
business goals are met through the sharing of knowledge, expertise
Led special regulatory projects/process initiatives of high complexity
Proactively managed critical issues, taking leadership for the regulatory
contribution
Supported executive team on due diligence, regulatory intelligence, and
regulatory affairs initiatives
Sanofi (through Kaztronix) Bridgewater, NJ Feb. 2013 to Nov. 2013
Regulatory Manager- External Pharmaceutical Production (Consultant)
Provided regulatory strategy to a topical product with manufacturing issues and
successfully resolved the issue by proposing an alternate manufacturing process
Provided regulatory assessment of post approval CMC changes for assigned FDA
approved products using electronic change control system
Worked closely with quality, manufacturing, regulatory and technical staff
throughout Sanofi worldwide locations and external manufacturers
Interfaced with FDA in defining/negotiating filing requirements for questions
related to CMC
Provided interpretation of CMC regulations and FDA guidance to internal project
team members and corporate partners
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DILIP KAUL, M. Pharm., M.S.
Valeant Pharmaceuticals Bridgewater, NJ Sep. 2011 to Jan. 2013
Senior Manager, CMC
Responsible for technical transfer of various pharmaceutical dosage forms from
client sites to our chosen CMOs
Contributed to regulatory strategy of technical transfer aspects- API vendors
change, process changes, excipients vendor changes and recommended whether
changes belongs to Annual Reportable or CBE-0 or 30 or PAS
Responsible for contributing to regulatory CMC sections of drug products and
API for NDA and ANDA Supplements, Annual Reports and DMF
Provided technical expertise to change control management and the impact of
proposed changes on regulatory filings
Excellent knowledge and experience of using GRESDA, DOMASYS and
Documentum based data management systems
Served as project team leader for multiple projects and chaired weekly and bi-
weekly meetings
Captured and provided meeting minutes and assigned responsibilities and
timelines associated with various critical and non-critical activities
Merck (Astrix Consulting) Kenilworth, NJ June 2011 to Sep. 2011
Regulatory CMC Consultant
Harmonizing electronic Common Technical Document (e-CTD) modules 2 & 3
sections of Marketing Authorization Applications related to global submission of
marketed drug products
Performing GAP analysis of e-CTD Modules 2 and 3 sections
Creating a single e-CTD document for future re-registration of drug products for
global markets
Pharmalink Consulting Inc. Short Hills, NJ Apr 2011 to May 2011
Senior CMC Specialist, Regulatory CTD Builds
Authored and reviewed eCTD sections of Modules 2 & 3
Point of contact for Pfizer sites and Product Principal
Performed CHMP/Gap Analysis
Sanofi-Aventis Bridgewater, NJ Jan 2009 to April 2011
Principal Research Investigator, Pharmaceutical Sciences Dept.
Actively participated as Pharmaceutical Sciences representative to CMC, Technical
Transfer and Project teams
Provided important support to Pharmaceutical development sections to support Phase
I-IIb studies including IND, IB, CTA, IMPD for three new chemical entities
Prepared and reviewed documents and data packages to support pharmaceutical
development and regulatory filings
Actively involved in writing and execution of batch records for clinical
manufacturing of investigational products
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DILIP KAUL, M. Pharm., M.S.
Met highly aggressive project timelines for development of Phase I-IIb formulations
which was proven to be safe and effective
Global coordination of pharmaceutical development
Sanofi-Aventis Bridgewater, NJ September 2005 to December 2008
Senior Research Investigator, Pharmaceutical Sciences Dept.
Actively participated and contributed to Pharmaceutical development sections to
support NDA and MAA for a late stage new chemical entity
Significantly contributed to Pharmaceutical development sections to support Phase I-
III studies including IND, IB, CTA, IMPD for two new chemical entities
Actively participated as Pharmaceutical Sciences representative to CMC, Technical
Transfer and Project teams
Participated in face to face meeting with FDA for end of Phase III meeting
Managed the technical transfer team for a solid drug product from Phase II-
commercial location
Aventis Bridgewater, NJ September 2001 to August 2005
Senior Research Scientist, Pharmaceutical Sciences Dept.
Actively contributed to Pharmaceutical development sections to support Phase I-II
studies including IND, IB, CTA, IMPD for four new chemical entities
Actively participated as Pharmaceutical Sciences representative to CMC and Project
teams
Evaluated and developed various solid dosage forms for multiple NCE
Managed the technical transfer team for a solid drug product from Phase II-
commercial location
Abbott Laboratories North Chicago, IL June 1999 to August 2001
Senior Research Scientist, Pharmaceutical Sciences Dept.
Successfully developed and filed ANDA for generic Cyclosporine equivalent-
Gengraf Solution and Gengraf Capsules available in the market globally
Managed to successfully develop and filed NDA and MAA for a novel HIV-Protease
inhibitor currently available in the market globally as Norvir and Kaletra solution,
capsules and tablets
Actively participated and contributed to Pharmaceutical development sections to
support NDA and MAA for a novel Protease inhibitor
Met highly aggressive timelines for submission of Pharmaceutical development
sections to support ANDA application for Cyclosporine generic
Team support to all IND/NDA submissions
Abbott Laboratories North Chicago, IL June 1993 to June 1999
Research Pharmacist, Pharmaceutical Sciences Dept.
Contributed to Pharmaceutical development sections to support NDA and MAA for a
novel Protease inhibitor
Contributed to Pharmaceutical development sections to support ANDA application
for Cyclosporine generic
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DILIP KAUL, M. Pharm., M.S.
Formulated novel controlled release dosage forms
Formulated novel semisolid dosage form in hard capsules
Yamamah Hospital Riyadh, Saudi Arabia February 1987 to August 1989
Assistant Pharmacist, Hospital Pharmacy
Responsible for filling in-patient prescriptions and monitored patient profiles
Raptakos, Brett & Co. Bombay, India April 1985 to February 1987
Production Supervisor, Consumer Product Manufacturing
Managed and supervised production and control of various types of liquid (solutions,
suspensions, emulsions, ointment, creams and gels) and solid dosage forms (tablets
and capsules) oral and external applications
Universal Generics Ltd. Bombay, India June 1984 to April 1985
Manufacturing Chemist, Generics Company
Supervised production of various generics tablet and capsule dosage forms
Hoechst Pharmaceuticals Bombay, India November 1983 to June 1984
Graduate Pharmacy Apprentice, Indian Subsidiary Company
Observed and worked under supervision in various sections-Tablet, Capsule, Liquid,
and Injectable
EDUCATION
Sept 1991- June 1993 Enrolled in Ph.D. program at Oregon State University
Completed all course requirements; Research work not completed.
Sept 1989- October 1991 MS in Pharmacy
University of Manitoba, Winnipeg, Canada
Sept 1981-February 1984 Master of Pharmacy
Institute of Technology, India
July 1977- August 1981 Bachelor of Pharmacy
Institute of Technology, India
AWARDS
Abbott Chairman’s Award
June 1996
Sept 1990- June 1991 Parke-Davis Canada Centennial Pharmacy Research Award
Oct 1981- Sept 1983 Senior Research Fellowship from University Grants Commission
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