Susan Simmons is a eficient professional, working in Ppd main office of which is in 871. on the position of Senior Manager, Global Regulatory Affairs since 2012. Susan Simmons has earned professional experience in more than 11 positions at various companies. Susan Simmons went to the Uc San Diego and was studying from 1986 to 1990. Carlsbad, California is the city, where this expert was known to be settled. This expert's phone number and email are easily accessed through this website by request.
Name variants:
Susanna Simmons,
Susannah Simmons,
Susanne Simmons,
Suzanne Simmons,
Sue Simmons,
Susie Simmons,
Susi Simmons,
Susy Simmons,
Suzie Simmons,
Suzy Simmons,
Sukie Simmons,
Sarah Simmons,
Ann Simmons,
Anna Simmons,
Anne Simmons,
Annie Simmons,
Sukey Simmons
Contact Information
Workplace
Colleagues
Work History
Senior Manager, Global Regulatory Affairs
929 north Front St, Wilmington, NC 28401
Regulatory consulting services for the Pharmaceutical, Biotech and Medical Device industries. Experienced in all phases of CMC, regulatory and medical writing for clinical and commercial app...
from Jul 2012
Senior Consultant
Responsibilities include generation and compilation of technical documents for submission to regulatory agencies (Briefing Documents, INDs, Module 3, NDA/eCTDs etc.). Main responsibilities i...
Feb 2008 — Jun 2012
Director, Regulatory Affairs, Analgesics
12481 High Bluff Dr, San Diego, CA 92130
Responsible for technology transfer of analgesic product and preparation for impending NDA/eCTD. Regulatory representative on all project teams, Primary responsibility for all strategic and ...
2006 — 2008
Senior Manager, Regulatory Affairs
Regulatory representative for the histamine dihydrochloride product and responsible for all regulatory communications and clinical/marketing submissions including INDs, eCTDs (NDA and MAA). ...
2004 — 2006
Senior Technical Associate, Regulatory Affairs
275 Grove St SUITE 101C, Newton, MA 02466
Responsibilities included compilation of technical documents for submission to regulatory agencies (Briefing Documents, INDs, sNDAs etc.). Additional job experience consisted of providing re...
2002 — 2004
Senior Regulatory Affairs Specialist
Primary contact for regulatory agencies (domestic and international). Regulatory responsibilities included: Preparation of a 510(k), IDE and IND, internal auditing, departmental representati...
2001 — 2002
Regulatory Associate
4435 Eastgate Mall SUITE 400, San Diego, CA 92121
Established and implemented systems to support the release of investigational product for clinical trials, investigational product export, domestic and international reporting of serious adv...
1999 — 2000
Senior Regulatory Affairs Associate
Developed and reviewed product labeling and promotional materials. Performed regulatory review of all advertising and promotional materials developed for a combination biologic/device, inclu...
1998 — 1999
Regulatory Affairs Associate
Prepared all periodic reports for multiple clinical protocols and indications. Reviewed and submitted final clinical/statistical reports for clinical investigations. Wrote the Manufacturing,...
1995 — 1998
Clinical Manufacturing Associate
Responsible for the manufacture of two product lines. Extensive experience in writing manufacturing and systems documentation and validation protocols. Supervisory experience for Assembly/Op...
1992 — 1995
Research Assistant, Methods Research and Product Development
Development of novel diagnostic methods using monoclonal antibody technology and optimization of existing in-vitro diagnostic assays.
1989 — 1992
Education
1986 — 1990
Occupations
Executive
Senior Manager
Senior Advisor
Operations Manager
Advisor
Skills
Regulatory Affairs
Fda
Regulatory Submissions
Clinical Trials
Sop
Validation
Gcp
Biotechnology
Ind
Medical Devices
Medical Writing
Technology Transfer
Clinical Research
FAQs about Susan Simmons
What's the main profession of Susan Simmons?
Susan is a Senior Manager, Global Regulatory Affairs.
What jobs is Susan Simmons proficient at at?
Susan Simmons is a professional Executive and Senior Manager jobs.
Where does Susan Simmons live?
Susan Simmons currently lives in Carlsbad, California.
Does the professional have the email address?
su**@ppd.com and ss**@live.com is Susan Simmons's email address.
How many companies did Susan Simmons work at?
The professional worked at 11 jobs.
What education does Susan Simmons have?
Susan studied at the Uc San Diego from 1986 to 1990.
What is professional industry that Susan Simmons is connected to?
This professional works in Pharmaceuticals industry.
Are there any special skills, that Susan Simmons has?
Susan has skills in the following areas: Regulatory Affairs, Fda, Regulatory Submissions, Clinical Trials, Sop, Validation, Gcp, Biotechnology, Ind, Medical Devices, Medical Writing, and Technology Transfer.