Senior Director Regulatory Affairs @ From September 2015 to Present (4 months) Director, Regulatory Affairs @ From February 2014 to September 2015 (1 year 8 months) Director, Regulatory Affairs @ From April 2012 to January 2014 (1 year 10 months) Director, Regulatory Affairs @ From July 2011 to April 2012 (10 months) Director, Regulatory Affairs @ Responsible for providing critical Regulatory corporate strategy, hands-on supervision and preparation of all aspects of regulatory dossiers and regulatory interaction in support of changes to and marketing of pharmaceutical FDA-approved products as well as diagnostic and development products. From January 2009 to February 2011 (2 years 2 months) Director, Regulatory Affairs @ Currently responsible for Regulatory Promotional Compliance oversight of advertising and promotion, scientific exchange and input into clinical trial design. Previous duties included postmarketing safety reporting, Labeling and Regulatory Compliance Committee representative for Amylin's development and commercial products. Managed a team of two Senior RA Managers 1 RA Manager and 3 RA Associates in coordination of these efforts. Performed training for external speaker development, Medical Sales Liaisons, Diabetes Care Liaisons and Commercial employees in OIG, FDA, HIPPA and FTC aspects. Developed ‘Good Promotional Practice’ and ‘Medical Affairs Guidelines’ documents with Commercial, Legal and Medical Affairs colleagues. From April 2008 to January 2009 (10 months) Associate Director, Regulatory Affairs @ From April 2003 to April 2008 (5 years 1 month) Associate Director, North American Regulatory Affairs @ Responsible for TKT’s developmental projects and directed three Regulatory Associates for 6 months until the VP Global RA was hired. Led RA team in projects such as a Canadian NDS update and Clarifax responses, FDA BLA Complete Response, and responses to Asian and Latin American regulatory agencies. Created Clearance Committee Review team in collaboration with Commercial Operations, to review and assess corporate promotional and educational material. Process involves team based review, comprised of representatives from Medical Affairs, Clinical Affairs, Legal, Safety and Marketing. Collaborated with law firm (Mintz Levin Cohn Ferris Glovsky and Popeo PC) to create corporate HIPPA compliant policies. From June 2001 to March 2003 (1 year 10 months) Senior Manager, International Regulatory Affairs @ Responsible for submissions for investigational applications and marketing licenses for Gene Activated™ proteins, Niche Protein™ products and Gene Therapy products to regulatory agencies worldwide (excluding North America). Led corporate response to EMEA Consolidated List of Questions to completion in 17 days. Collaborated with international consultants to submit Replagal (agalsidase alfa) marketing applications and to secure approvals in 22 countries. From August 2000 to June 2001 (11 months) Senior Regulatory Affairs Associate @ Appointed Regulatory Affairs Team Leader (11/99) for recombinant Factor IX (BeneFIX®) and recombinant IL-11 (Neumega) products. Coordinate the efforts of five Regulatory professionals in matrix teams for worldwide registration efforts. Member of recombinant Factor VIII (ReFacto) Regulatory registration team. From July 1998 to August 2000 (2 years 2 months) Regulatory Affairs Assistant @ Supported and assisted with IND submissions for the world’s first transgenically produced (goat’s milk derived) protein. Assisted with the French Viral Safety Committee submission, application approved 11/97, OELPS informational package, and Pre-CTX submission. Reported serious adverse events to FDA from Phase I/II trials. From January 1997 to March 1998 (1 year 3 months) Regulatory Affairs Associate I @ Supported Regulatory strategy and submissions for Phase III worldwide clinical trial initiative. Wrote, organized, and submitted a Certificate for Clinical Trials Exemption (CTX) approved by the Medicines Control Agency (UK). CTX document used for subsequent successful clinical trial initiation applications for Sweden and Germany. Drafted, reviewed and edited labeling documentation to ensure worldwide clinical labeling compliance. Gathered data and created an informational database for eventual BLA/MAA submissions. From 1994 to 1998 (4 years) Quality Assurance Coordinator @ Main duties included processing and controlling the documentation for facilities, processes, and systems as required by the current Good Manufacturing Practices (cGMP) regulations and as required by the National Standards (9000-1 and 9000-2). Provided guidance to Quality Assurance Documentation Specialists and to temporary employees. Developed and issued documentation status reports. Coordinated SOP implementation. Presented cGMP documentation training. Wrote QA departmental SOPs. Assisted with Inspection, Labeling, and AQL of Product and Returned Goods. From November 1994 to December 1996 (2 years 2 months) Quality Assurance Documentation Clerk @ Processed correct, clear, concise and consistent cGMP documentation. Worked with primary users of documentation to transmit the documentation into written form. Updated user SOP books. Issued document change requests. From May 1994 to November 1994 (7 months)

MBA, International Business @ Boston College - Wallace E. Carroll Graduate School of Management From 1998 to 2002 Dickinson College From 1989 to 1993 Andrew Henderson, MBA, RAC is skilled in: Regulatory Affairs, FDA, Compliance, Clinical Trials, IND, Clinical, Biotechnology, cGMP, Pharmaceuticals, Clinical Development, Regulatory Submissions, Pharmacovigilance, Oncology, Quality Assurance, EU