Diane Stroehmann

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.

Experience

1. Senior Vice President, Regulatory Affairs

   Viridian Therapeutics, Inc.

   Jun 2024 — Present · Waltham, MA, US

Education

• University of Illinois Urbana-Champaign

  BS, Biology

• San Diego State University

  MS, Regulatory Affairs

Skills

• U.s. Food and Drug Administration (Fda)
• Dermatology
• Glp
• Pharmaceutics
• CRO
• Ectd
• Ctms
• Regulatory Submissions
• Clinical Development
• Good Clinical Practice (Gcp)
• Standard Operating Procedure (Sop)
• Change Control
• Regulatory Affairs
• Lifesciences
• Technology Transfer
• Life Sciences
• Biotechnology
• U.s. Title 21 Cfr Part 11 Regulation
• Clinical Trial Management System (Ctms)
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Regulations
• Regulatory Requirements
• Ind
• Pharmacovigilance
• Gmp
• Good Laboratory Practice (Glp)
• Drug Development
• Gcp
• Biologics
• Medical Affairs
• Cmc
• Medical Devices
• Clinical Research
• Capa