Timothy A. Candy
Principal Consultant at Opus Regulatory, Inc.
- Role
- Principal Consultant at Opus Regulatory Inc.
- Location
- Omaha, NE, US
- LinkedIn followers
- 500 followers
About Timothy A. Candy
Experienced Director Global Regulatory Affairs with a demonstrated history of working in the biotechnology industry. Skilled in Medical Devices, Biotechnology, Regulatory Requirements, U.S. Food and Drug Administration (FDA), and Clinical Affairs.
Experience
Principal Consultant
Oct 2017 — Present
Provide Regulatory Affairs – Advertising & Promotion expertise and support for clients, including but not limited to:o Performing strategic, risk-based review/approval of advertising/promotional copy for all material audiences and formats, including U.S, Canada, and Europeo Performing submissions review: 2253; Subpart H; Requests for Advisory Comment/launch package submissions; competitor complaint letters; Pharmaceutical Advertising Advisory Board (Canada)o Attending team meetingso Providing concept consultationso Participating in publication review committees and other Medical Affairs material review committeeso Drafting/reviewing relevant regulatory and compliance policies & procedureso Performing compliance audits (Ad/Promo, speaker programs, publications, advisory boards)o Training (creation and presentation, sales training)o Mentoring junior staff and transitioning new hires/leadership
Education
University of Nebraska Medical Center
Doctor of Pharmacy (PharmD)
1998 — 2002
The Ohio State University
Master of Science (MS), Health-Systems Pharmacy Administration
2003 — 2005
University of Nebraska at Kearney
Pre-Pharmacy Studies
1996 — 1998
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