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Tracy Rockney, JD

Co-Founder & Managing Partner

Co-Founder & Managing Partner at OneSource Regulatory, LLC

Greater Chicago Area

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Tracy Rockney, JD's Email Addresses & Phone Numbers

Tracy Rockney, JD's Work Experience

OneSource Regulatory, LLC

Co-Founder & Managing Partner

May 2015 to Present

Greater Chicago Area


Vice President, Regulatory Affairs

May 2010 to May 2015

Greater Chicago Area


Sr. Director, Regulatory Affairs

January 2005 to April 2010

Tracy Rockney, JD's Education

Washburn University School of Law

Juris Doctor Law

1989 to 1992

University at Albany, SUNY

1985 to 1989

Tracy Rockney, JD's Professional Skills Radar Chart

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Tracy Rockney, JD's Estimated Salary Range

About Tracy Rockney, JD's Current Company

OneSource Regulatory, LLC

OneSource Regulatory is a regulatory consulting and technology company specializing in regulatory strategy, advertising and promotion, and drug product labeling.

Frequently Asked Questions about Tracy Rockney, JD

What company does Tracy Rockney, JD work for?

Tracy Rockney, JD works for OneSource Regulatory, LLC

What is Tracy Rockney, JD's role at OneSource Regulatory, LLC?

Tracy Rockney, JD is Co-Founder & Managing Partner

What is Tracy Rockney, JD's personal email address?

Tracy Rockney, JD's personal email address is t****[email protected]

What is Tracy Rockney, JD's business email address?

Tracy Rockney, JD's business email addresses are not available

What is Tracy Rockney, JD's Phone Number?

Tracy Rockney, JD's phone (**) *** *** 294

What industry does Tracy Rockney, JD work in?

Tracy Rockney, JD works in the Pharmaceuticals industry.

About Tracy Rockney, JD

📖 Summary

Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. Tracy is the Co-founder and Managing Partner of OneSource Regulatory, a regulatory consulting and technology company specializing in regulatory strategy, advertising and promotion, and drug product labeling. She is also the Regulatory Officer in Residency at Doctor Evidence, a software company committed to advancing knowledge acceleration through the use of its advanced DOC—Digital Outcome Conversion—integrated software platform in Evidence-Based Medicine (EBM) decision making. Tracy's senior regulatory management experience includes the following roles - Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence at AbbVie (formerly Abbott Pharmaceuticals), Senior Director, Global Regulatory Affairs at Shire Pharmaceuticals, Director, Regulatory Affairs at Wyeth, and Director, Global Regulatory Strategy at Pfizer. Tracy received her Juris Doctor from Washburn University School of Law, and her Bachelor of Arts from the University at Albany, State University of New York, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor for Daylan Pharmaceuticals, a start-up company conducting ophthalmology research, and a board advisor for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases. Tracy is currently a steering committee member on the DIA/HBA Leadership Project which was formed by the Drug Information Association (DIA) and the Healthcare Businesswomen’s Association (HBA) to advance the careers of women in regulatory, medical, legal and compliance. She is the Chair for the DIA Regulatory Advertising & Promotion Working Group. She was a member of the FDLI planning committee for the 2012 Advertising & Promotion conference.Co-Founder & Managing Partner @ OneSource Regulatory is a regulatory consulting and technology company specializing in regulatory strategy, advertising and promotion, and drug product labeling. From May 2015 to Present (8 months) Greater Chicago AreaVice President, Regulatory Affairs @ Vice President, Regulatory Affairs - Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence AbbVie executive – considered a unique people and cross-functional leader. Led the Global Labeling, Global Advertising, and US Advertising & Promotion function (90 staff/20 consultants) for all AbbVie brands. Provided strategic oversight for marketed product promotion strategies. Provided strategic labeling, advertising and promotion input into clinical programs for all development compounds, with a focus on maximizing product labeling for optimal promotion at approval as a member of the Global Regulatory Product Team. Member of Regulatory Affairs Leadership Team, responsible for providing leadership, guidance and input into development programs for all AbbVie compounds. Led the Regulatory Policy & Intelligence function (15 staff) based in Chicago, Washington D.C., London and Singapore. Provided strategic direction and oversight for global regulatory policy issues, including external influence through advocacy and membership on key industry working groups, and direct interaction with health authorities and policy makers. Managed multi-million dollar budget for the following global labeling and advertising initiatives: • Global labeling migration – migration of over 4000 global affiliate labels into one validated system • Global labeling alignment – Aligning all global affiliate labels to the CCDS across all brands • Regulatory history documents – development of OPDP/DDMAC history for all marketed products, including summary of relevant labeling history and product-class comments by OPDP • Core claims documents – development of product core claims summaries for all marketed products From May 2010 to May 2015 (5 years 1 month) Greater Chicago AreaSr. Director, Regulatory Affairs @ Therapeutic Area Head – Gastrointestinal Business Unit Provide regulatory leadership for gastrointestinal franchise, including strategic and tactical leadership for ulcerative colitis and diverticulitis products/compounds post-proof of concept, and post-approval life-cycle management. Member of Joint Development Committee formed in support of EU submission activities with partner company for celiac compound in Phase II. Global CMC Service Area Lead Support Shire’s generalist regulatory model by providing global CMC leadership cross- therapeutically. Supported by two Shire CMC regulatory experts. Responsibilities include review and approval of all CMC strategic plans, streamlining and supervision of global change control process, and review of all pre- and post-approval CMC submissions. Due Diligence/Business Development Liaison U.S. Executive Advertising and Promotion Representative/Service Area Lead From January 2005 to April 2010 (5 years 4 months) Executive Director, Professional Education @ Overall Responsibilities – Direct Wyeth grant giving and program development for the support of independent medical education for global, national, regional and local programs for all Wyeth therapeutic areas – Neuroscience, Oncology, Hematology, Transplant, Cardiovascular, GI, Musculo- Skeletal, Women’s Health, Immunology, Infectious Disease, and Vaccines. Manage department budget - $2 million. Direct approximately $100 million in grant giving. From May 2004 to January 2005 (9 months) Director, Worldwide Regulatory Affairs @ CNS, Musculo-Skeletal, Oncology, Women’s Health & Transplant. Overall Responsibilities – Provided post-approval regulatory affairs support and new product strategic support for four therapeutic areas – Neuroscience, Musculo-Skeletal, Oncology, Women’s Health and Transplant. Provide global (US and affiliate) support for the Effexor, Sonata, Enbrel, Synvisc, Neumega, Mylotarg, Women’s Health and Rapamune brand teams. From April 2002 to May 2004 (2 years 2 months) Director, Regulatory Affairs @ Director, Regulatory Affairs - Worldwide Regulatory Strategic Operations (December 2001 to March 2002) Overall Responsibilities - Principal regulatory support on Lipitor product team for all regulatory matters associated with PPG's pharmaceutical business interests on a worldwide basis, maintaining a global perspective on product specific regulatory issues that are relevant to the product team objectives, including product development matters, registration issues, commercial programs and marketing plans. Pfizer Inc, Animal Health Group (August 1993 to December 2001) The Pfizer Animal Health product line includes prescription and over-the-counter companion animal and livestock pharmaceuticals and vaccines. Animal health pharmaceutical products are subject to the same FDA regulations as human pharmaceuticals. Director, Regulatory Affairs (December 2000 to December 2001) Managed product line expansion for companion animal and livestock products including, prescription antibiotics, sedative/analgesics, non-steroidal anti-inflammatory drugs, parasiticides, endectocides and over-the-counter drug products marketed by Pfizer Animal Health. Responsible for the development of regulatory strategy for Phase III, IIIb and Phase IV clinical trials. Provide regulatory input into clinical development programs for the US. Responsible for communication and negotiation of label expansions and changes with the US Food and Drug Administration, Center for Veterinary Medicine (FDA/CVM). Associate Director, Regulatory Affairs (January 2000 to December 2000) Manager, Regulatory Affairs (April 1998 to December 1999) Associate Manager, Regulatory Affairs (January 1996 to March 1998) Regulatory Associate, Regulatory Affairs (August 1993 to December 1995) From August 1993 to March 2002 (8 years 8 months) Greater New York City AreaJuris Doctor, Law @ Washburn University School of Law From 1989 to 1992 University at Albany, SUNY From 1985 to 1989 Tracy Rockney, JD is skilled in: Regulatory Affairs, Pharmaceutical Industry, Oncology, Regulatory Submissions, Clinical Trials, NDA, Biotechnology, Drug Development, FDA, Gastroenterology, Regulatory Requirements, Market Access, Clinical Development, CMC, Pharmaceutics

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In a nutshell

Tracy Rockney, JD's Personality Type

Introversion (I), Intuition (N), Feeling (F), Judging (J)

Average Tenure

3 year(s), 9 month(s)

Tracy Rockney, JD's Willingness to Change Jobs



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