Ross MacLean Email & Phone Number
Chief Operating Officer and Head of Development
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Ross MacLean Location
- Canada
Ross MacLean Work
- 2023 -now Chief Operating Officer and Head of Development @ Undisclosed Biotech
- 2022 -now Regulatory Lead (Consultant) @ Undisclosed US Biotech
- 2021 -now Venture Partner @ Akkadian Partners
- 2019 -2021 Chief Regulatory Officer and EVP Translational Medicine @
- 2018 -2019 Executive Vice President Global Regulatory Affairs and Compliance @
- 2016 -2017 Vice President Global Regulatory Affairs Cynapsus Therapeutics @ Cynapsus Therapeutics
- 2013 -2016 Senior Vice President, Scientific and Regulatory Affairs @
- 2011 -2012 Vice President Global Regulatory Affairs @
- 2010 -2011 Director and Owner @ RJM Consultancy
- 2008 -2010 Global Head of Regulatory Affairs @
- 2004 -2007 Directeur Général and CEO @ DrugAbuse Sciences Inc.
- 2004 -2004 Dir Regulatory Affairs @ Powderject
- 1999 -2004 VP Global Regulatory Affairs @ SangStat Medical
- 1998 -1999 Head of Regulatory Affairs @ BIOS (Consultancy and Contract Research)
- 1995 -1998 Team Leader Regulatory Affairs @ Sanofi Pharma
- 1992 -1995 Regulatory Affairs Officer @ Merck Generics (formerly Generics UK)
Ross MacLean Education
- University of Southampton 1985-1988
Ross MacLean Skills
- Briefing
- Regulatory Operations
- MAAs
- Regulatory Interactions
- Global Regulatory Compliance
- Executive Leadership
- Validation (Drug Manufacture)
- Drug Discovery
- Investigational New Drug Application (IND)
- Key Opinion Leaders
- New Drug Application (NDA)
- Resource Allocation
- Regulatory Filings
- Regulatory Policy
- Regulatory Affairs
- Pharmaceutical Industry
- Clinical Development
- Regulatory Submissions
- Biopharmaceuticals
- Drug Development
- Pharmacovigilance
- Pharmaceutics
- Medical Affairs
- Biotechnology
- Clinical Trials
- FDA
- GCP
- CRO
- Life Sciences
- Technology Transfer
- Regulatory Requirements
- GLP
- Product Development
- Business Strategy
- GMP
- Quality Assurance
- R&D
- Management
- Data Integrity
- Interpreting Data
- Regulatory Compliance
- CRO Management
- Research and Development (R&D)
- Good Clinical Practice (GCP)
- U.S. Food and Drug Administration (FDA)
- Good Laboratory Practice (GLP)
- Corrective and Preventive Action (CAPA)
- Regulations
- Strategic Planning
- Standard Operating Procedure (SOP)
- U.S. Title 21 CFR Part 11 Regulation
- Cross-functional Team Leadership
- Change Control
- Quality System
- Formulation
- Good Manufacturing Practice (GMP)
- Lifesciences
- Biosimilars
- Beach volleyball
- Development
- Good Laboratory Practice Glp
- Regulatory
- Good Clinical Practice Gcp
- Corrective and Preventive Action Capa
- Research and Development R&d
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Good Clinical Practice
- u.s. Food and Drug Administration
- Good Laboratory Practice
- Research and Development
- Standard Operating Procedure
- Corrective and Preventive Action
Ross MacLean Summary
- Ross MacLean, based in Canada, is currently a Chief Operating Officer and Head of Development at Undisclosed Biotech. Ross MacLean brings experience from previous roles at Undisclosed US Biotech, Akkadian Partners and Sublimity Therapeutics. Ross MacLean holds a 1985 - 1988 University of Southampton. With a robust skill set that includes Briefing, Regulatory Operations, MAAs, Regulatory Interactions, Global Regulatory Compliance and more. Ross MacLean has 1 emails on RocketReach.
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