Project Manager Quality Assurance
Resume:
Scotch Plains, New Jersey *****
Phone: 908-***-****
Fax: 908-***-****
E-mail: ****@*********.***
Rhea Naomi Qualls Williams, M.P.H.
Results-oriented regulatory affairs professional
With 19-year successful track record
Offering Strong leadership and strategic management skills. Extensive submissions experience.
Expertise in interfacing with FDA divisions as well as developing and executing regulatory
strategy. Success in providing developmental and marketed product support. Consulting
on a diverse portfolio of products and applications throughout pharmaceutical industry.
Key US Designated Agent (Sole Regulatory Support)
•
Achievements o Conducted Pre-IND meeting and successfully submitted and opened eIND for
an International Pharmaceutical company.
o Responsible for pharmacovigilence, completed product assessments, cumulative
reporting and AER reviews.
o Provided regulatory, CMC and quality assurance support. Wrote CMC and
Nonclinical summary documents for US and Canadian submissions.
o Maintained Canadian CTA for Phase III studies.
Regulatory Affairs
•
o Submitted 30+ volume INDs in CTD format in less than 6 weeks with the
INDs successfully opened.
o Led meetings with FDA involving division directors from the Oncology,
Neuropharm, DDMAC, DRUDP, DAARP, Special Pathogens and Anti-
Infective divisions.
o Submission of paper and electronic Orphan, IND, NDA, 510k, IDE and ANDA
applications.
o Drafted QOS and Module 3 documents for IND, CTA and ANDA submissions.
o Established and maintained advertising and promotion review committee;
maintained and submitted promotional materials to DDMAC. Submitted letter
of complaint to DDMAC resulting in compliance letter to competitor.
o Presented to FDA’s Oncology Drugs Advisory Committee.
o Performed regulatory due-diligence evaluations for multiple products, resulting
in one product purchase and one product in-license.
o Extensive experience with FDA Divisions, working with prescription drugs,
biologics and devices as well as OTC and generic drugs.
Secord Inc.
Rhea Williams, MPH
Page 2 of 5
2000-present
Experience Secord Inc.
Consultant
• Act as sole FDA support for pharmaceutical companies.
• Providing regulatory expertise and liaison support for clients in
various therapeutic areas. Write, compile and submit IND,
CTA, NDA, MAA and ANDA applications in both paper and
electronic CTD format.
• Leading a group of professionals with diverse regulatory and
quality assurance expertise as well as providing information
management services responding to pharmaceutical industry’s
critical need for informed, objective and customized regulatory
support.
2001-2004
Eisai Medical Research Inc. and Eisai Inc.
Director, Regulatory Affairs
Provided regulatory strategy and submission planning for
•
development and marketed products in CNS franchise.
Coached team for presentation to FDA’s Peripheral and Central
•
Nervous System Advisory Committee.
Managed regulatory strategy, submission and maintenance for several
•
products simultaneously: 4 pre-IND, 9 IND, 1 pre-NDA, 2 NDA
and 3 sNDA applications.
Responsible for advertising and promotion review for five products,
•
PDMA compliance, Phase IIIb/Phase IV support and regulatory
training for sales representatives.
Supervised staff of 11.
•
Represented regulatory on due diligence teams.
•
1999-2000
B&H Consulting Services, Inc.
Project Manager, Regulatory Affairs
Coordinated new drug development projects for large pharmaceutical
•
companies; commented on NDA CMC and Clinical summary
documents.
Facilitated electronic submission of Items 11 and 12.
•
Prepared teams for FDA meeting.
•
Secord Inc.
Rhea Williams, MPH
Page 3 of 5
1998-1999
Schering-Plough Research Institute
Associate Manager, Regulatory Affairs
Provided regulatory support for oncology NMEs and one marketed
•
product. Worked with team to present to ODAC.
Submitted orphan drug designation and Appendix M applications.
•
Served as primary contact for CDER and CBER divisions of FDA
•
and ORDA and RAC of NIH for oncology drugs and biologics.
1995-1998
Johnson & Johnson, Advanced Care Products
Associate, Regulatory Affairs
Served as regulatory representative on product teams and supported
•
product launches for Rx, OTC and 510k women’s health products.
Conducted mock PAI inspections and participated in
•
investigation/issuance of exception control reports.
Prepared and submitted supplements, amendments and maintenance
•
reports to active IND and NDA applications.
1994-1995
Colgate-Palmolive Company
Assistant, Regulatory Affairs
Involved with all phases of NDA, IND and ANDA submission
•
process.
Wrote summaries for Clinical and CMC sections of annual reports.
•
Conducted regulatory intelligence review.
•
Education Columbia University
M.P.H., Sociomedical Sciences
University of Pennsylvania
B.A., Psychology
Certifications Regulatory Affairs Professional Society, November 1997
Regulatory Affairs Certification
Secord Inc.
Rhea Williams, MPH
Page 4 of 5
Long Term Consulting Project Descriptions
2012 - Present
Confidential Company Name
C
Consultant, Regulatory Affairs
Provide regulatory support for marketed products: advertising and
•
promotion, NDA support and coordinate IND submission.
2012 - 2013
Confidential Company Name
C
Global Drug Safety Associate
Proactively assess and review post-marketing safety reports of mature
•
products through aggregate reporting.
Conducted adverse event reports/signaling reviews for 30+ products.
•
Write safety response for Health Authority questions and requests.
•
Write Periodic Benefit Risk Evaluation Reports (PBRER).
•
2010 - 2012
Confidential Company Name
C
Acting Director, Regulatory Affairs
Sole FDA contact for US pharmaceutical company.
•
Successfully led Type A meeting.
•
Provide regulatory support for marketed products, advertising and
•
promotion and PDMA activities.
Coordinate and publish all regulatory maintenance activities,
•
including NDA preparation, annual reports and drug listings.
Confidential Company Name 2008 - 2010
C
Designated US Agent
Sole FDA contact for non-US pharmaceutical company.
•
Coordination and publishing of maintenance DMF and drug listing
•
submissions.
Confidential Company Name 2007 - 2010
C
Designated US Agent
Sole FDA contact for non-US pharmaceutical company.
•
Led Pre-IND meeting.
•
Coordinated and published Original IND in CTD format.
•
Coordination of maintenance IND submissions.
•
Secord Inc.
Rhea Williams, MPH
Page 5 of 5
Stiefel Laboratories 2005 - 2007
Acting Director, Regulatory Affairs
Advertising and promotion review for marketed products.
•
Sales and marketing training.
•
Supervision of 5 consultants.
•
Regulatory lead on International project team.
•
Led two pre-IND meetings.
•
Coordinated and published two Original INDs in CTD format;
•
submitted the two INDs in paper format to two different Divisions.
Supervised submission of 3 ANDA applications.
•
Participated in senior-level development and marketing meetings.
•
Supervised maintenance of 20 NDA and ANDA applications and 10
•
IND applications.
Coordinated submission of International requests for scientific
•
advice.
2004-2007
Johnson & Johnson, Consumer Products Worldwide
2000-2001
Consultant
Advertising and promotion review for marketed products.
•
Sales and marketing training.
•
Creation of PDMA presentation.
•
Labeling modification and submission for all marketed product labels.
•
Writing toxicology section of Original IND.
•
Coordinating toxicology section of Original NDA in eCTD format.
•
Altana Pharma 2005
Consultant
Advertising and promotion review for marketed products.
•
Sales and marketing training.
•
Support of active INDs.
•
Regulatory representative on International project team.
•
Anthra Pharmaceuticals, Inc. 2001
Acting Director, Regulatory Affairs
Sole regulatory personnel for one marketed oncology NDA product.
•
Submitted all safety reports for ongoing studies to FDA and HPB.
•
Reviewed and submitted all maintenance submissions for ongoing
•
IND and CTA applications.
Contact this candidate