Unifers.ai

Diane Stroehmann

Senior Vice President, Regulatory Affairs @Viridian Therapeutics, Inc.

Boston, MA, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Jun 2024 — Present

Senior Vice President, Regulatory Affairs @Viridian Therapeutics, Inc.

View department →

Waltham, MA, US

EDUCATION

N/A

University of Illinois Urbana-Champaign

BS, Biology

N/A

San Diego State University

MS, Regulatory Affairs

SKILLS

U.s. Food and Drug Administration (Fda)DermatologyGlpPharmaceuticsCROEctdCtmsRegulatory SubmissionsClinical DevelopmentGood Clinical Practice (Gcp)Standard Operating Procedure (Sop)Change ControlRegulatory AffairsLifesciencesTechnology TransferLife SciencesBiotechnologyU.s. Title 21 Cfr Part 11 RegulationClinical Trial Management System (Ctms)Clinical TrialsPharmaceutical IndustrySopFda21 Cfr Part 11RegulationsRegulatory RequirementsIndPharmacovigilanceGmpGood Laboratory Practice (Glp)Drug DevelopmentGcpBiologicsMedical AffairsCmcMedical DevicesClinical ResearchCapa

ABOUT DIANE STROEHMANN

Highly experienced and strategic Regulatory Affairs executive with 25 years of experience in the biopharmaceutical industry. Recognized as a strong leader, mentor and team player who is collaborative and resourceful. Broad expertise in developing global regulatory strategy and ensuring regulatory compliance for small molecules and biologics. Global experience in all phases of pharmaceutical development – from discovery through clinical development (IND, CTA) to marketing approval (NDA, BLA, MAA, NDS). Proven ability in developing effective regulatory strategies, interacting with regulatory agencies and delivering high quality and compliant submissions resulting in successful outcomes and commercialization.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.