Dorothy Engelking has been working as a VP Regulatory Affairs in Neos Therapeutics since 2010. Furthermore, Dorothy has an employment history at more than seven companies in the related field. Dorothy has a total work experience of 24+ years. Dorothy Engelking studied at the South Dakota School of Mines and Technology from 1979 to 1985. Today Dorothy Engelking lives in Dallas, Texas region. You can find this professional's current email address and number with SoftwareOfficial search.
Name variants:
Dorothea Engelking,
Dora Engelking,
Dorrie Engelking,
Doll Engelking,
Dolly Engelking,
Dodie Engelking,
Dot Engelking,
Dottie Engelking,
Dotty Engelking,
Dee Engelking
Contact Information
Last Update
Jul 8, 2022
Email
dj**@gmail.com, de**@neostx.com, do**@knetik.com
Location
Dallas, TX
Company
Workplace
Colleagues
Work History
VP Regulatory Affairs
Lead Regulatory strategy for new product development candidates. Provide critical regulatory advice to product development teams. Provide key resource for and oversight of developing company...
from Apr 2010
Vice President
Directed clinical trial startup, handled document management, and spearheaded investigator relations departments encompassing 150+ global employees. Fostered productive client relationships,...
Jul 2008 — Jul 2009
Sr. Vice President, Regulatory Affairs
Adeptly guided daily operations of 5-member regulatory affairs department. Functioned as key player in organizational decision-making as member of executive management team. Initiated planni...
Mar 2006 — Jul 2008
VP Regulatory Affairs
Promoted consistently through increasingly responsible management roles to oversee a team of 20 responsible for developing regulatory strategies for product development candidates within bra...
Jan 1999 — Mar 2006
Director, Regulatory Affairs
Delivered skilled leadership for a team of 10. Formulated regulatory strategies for product development candidates. Coordinated communications with regulatory agencies and liaised with regul...
Jun 1993 — Jan 1999
Regulatory Affairs Associate
Coordinated the preparation of ANDA filings for solid oral dosage forms.
Responsible for the format and content of the packaging section of the ANDA.
Responsible for answering deficiency let...
Jan 1991 — Jan 1993
Q.A. Professional
Prepared CMC section of IND, NDA, NADA, and international product registration documentation for solid oral dosage forms, liquids, ointments, and sterile products.
Served on various assigned...
Jul 1985 — Jan 1991
Education
1979 — 1985
Occupations
Executive
Vice President
Investigator
Chief Executive
Skills
Fda
Regulatory Affairs
Software Documentation
Pharmaceutical Industry
Ind
Clinical Trials
Cross Functional Team Leadership
Strategy
Nda
Anda
Gmp
Regulatory Submissions
Sop
Cmc
Product Development
Clinical Development
Drug Development
Capa
Standard Operating Procedure
U.s. Food and Drug Administration
Regulatory Requirements
Regulations