Since 2019, Randy Aquipel has been working in Catalyst Biosciences situated 1092, 1092. This expert is an experienced Director Regulatory Affairs with over 12 years of work experience. According to Randy's CV and work profile, this expert has worked at more than 12 places with numerous backgrounds and gained different skills. Randy studied at the Pacific University from 1987 to 1991. This professional has professional certification in Regulatory Affairs Certification E.u. and Regulatory Affairs Certification U.s.. San Francisco, California is the place where this expert presently lives. You can contact with Randy by searching for phone or email address or find additional information by requesting access to the person's details.
Name variants:
Randall Aquipel,
Randolph Aquipel,
Miranda Aquipel
Last updated Jun 03, 2024
Contact Information
Workplace
Colleagues
Work History
Director Regulatory Affairs
611 Gateway Blvd, South San Francisco, CA 94080
from Jul 2019
Associate Director Regulatory Affairs
8000 Marina Blvd SUITE 300, Brisbane, CA 94005
from Apr 2016
Associate Director Regulatory Affairs
1020 east Meadow Cir, Palo Alto, CA 94303
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovere...
from May 1, 2012
Associate Director Regulatory Affairs and Compliance
25801 Industrial Blvd SUITE B, Hayward, CA 94545
Aug 2010 — May 2012
Senior Manager Regulatory Affairs and Compliance
3101 Western Ave #600, Seattle, WA 98104
Responsible for leading the submission of applications to regulatory agencies, liaison with regulatory authorities, and provided guidance to project teams for assigned oncology projects/prod...
Nov 2009 — Aug 2010
Ra and Qa and Gcp
Supported and maintained GCP audit program and assisted Regulatory and QA on specified projects reporting to VP of Regulatory and QA. Authored GCP audit plan, developed processes/tools to im...
Jun 2009 — Nov 2009
Senior Manager Regulatory Affairs
Supported development programs (CV and Pain) reporting to Sr. VP of Product Development & New Product Planning. Responsible for all department operations: representing regulatory on project...
Oct 2008 — Apr 2009
Manager Regulatory Affairs
Managed Regulatory Affairs department and reported to VP of Development & Regulatory Affairs. Responsible for 5 IND programs (Oncology) and CTAs outside the US, and provided support to clini...
Jul 2007 — Sep 2008
Manager Regulatory Affairs
North Carolina
Regulatory liaison assigned to R&D development and commercial projects (Dermatology). Reviewed clinical and CMC documents, labeling, and promotional materials ensuring compliance and accurac...
Nov 2006 — Jun 2007
Senior Regulatory Affairs Associate
455 Msn Bay Blvd, South San Francisco, CA
Represented Regulatory across company and partnered programs (inhalation and PEGylated products). Interacted directly with team members in clinical, CMC, and life sciences, and participated ...
Jan 2005 — Nov 2006
Associate I and Ii Regulatory Affairs
Associate I: Liaison assigned to general & women’s health product lines (NDAs, ANDAs and INDs). Compiled and wrote annual reports and PSURs, reviewed and submitted expedited safety reports, ...
Apr 2000 — Jan 2005
Education
1987 — 1991
Occupations
Executive
Director
Scientist
Biotechnology Professional
Deputy Director
Operations Manager
Biologist
Biological Scientist
Deputy Manager
Chief Executive
Skills
Regulatory Submissions
Regulatory Affairs
Fda
Ind
Pharmaceutical Industry
Gcp
Clinical Trials
Ectd
Nda
Clinical Research
Drug Development
Biotechnology
Gmp
Cro
Cmc
Sop