David McGregor, Ph.D., is a Director with Protocol Link and has 10 years experience in the pharmaceutical and biotechnology industries. David has held significant management positions in Operations, Manufacturing Technology, Validation, Project Management and Regulatory for major pharmaceutical companies.Specialties: Expertise in process and analytical test method validation and transfer, ANDAs, laboratory management, Regulatory Submissions, Project Management, Deviation Investigations, CAPA management, Due Diligence.

Technical Lead Latin American Import Testing Support. Driving new business processes, compliance of regulatory dossiers, technical support. CRO support, client management, scoping, quoting, workload management into department. API Regulatory Drug Master File updates per FDA GDUFA requirements, determine cost effectiveness and fate of API portfolioGlobal Associate Director Regulatory Affairs/Project Manager/Technical Manager with significant progressive experience utilizing scientific, technical management, regulatory and project management skills. Unique ability to lead teams and build consensus to execute on plans, resolve complex problems, develop new business processes and deliver goals on time. Expertise in quality, compliance with regulations and industry codes in dynamic highly regulated pharmaceutical and chemical industries. Project Management: Management and oversight of compliance/remediation, technical/regulatory activities, business process development/improvement in support of commercial pharmaceutical products.Regulatory: Skilled in CMC documentation and systems. ANDA, GDUFA, DMF activities and regulatory strategy creation. Technical Management: Extensive experience in technical team management. Leading validation teams, R&D and physicochemical groups specializing in problem solving and methods development. Specialties: Analytical Chemistry, ICH guidelines, Remediation, Regulatory, Compliance, Validation, DMF, NDA, CEP, CMC, Project Management, Business Process Improvement

CMC support for marketed productsRegulatory Strategy creationAnnual Updates

Product Support for Commercial Established Pharmaceuticals.Project Management for Commercial Established PharmaceuticalsManagement of a team of Product Support Scientists

Technical Manager in charge of remediation and compliance for ICH guidelinesManage Validation ScientistsProject Management of Compliance Program for Abbott

Lead/Managed Analytical and Physical Laboratories in support of Research and ManufacturingTechnical Product management for Biodiesel business

Methods Development / Process Improvement through Process Analytical Technology Implementation

Graduate research funded by the Human Genome Project (DOE) to improve the mapping efficiency of human genome.