Mark W. Machado
Upton,MA
Summary
Twenty plus years of experience in various capacities within Regulatory Affairs, e.g., therapeutic area strategy, operations and CMC in early through late stage clinical development, marketing application filing and post-approval. Experience with both small and large molecules, leading and preparing teams for Health Authority interactions, execution of program goals and supervision of staff. Accomplished at executing development plans within timelines and budget.
Overview
37
37
years of professional experience
Work History
Senior Director, Regulatory Affairs
BeiGene USA, Ltd
01.2022 - Current
- Collaborate with cross-functional heads to execute development plans within timelines and budget
- Define regulatory strategies and directed submission activities, liaison for HA interactions, lead meetings and prepare briefing packages
- Critically evaluate strategic direction of programs and provide RA input to leadership based on changing regulatory landscape and competitive environment
- Coach direct reports (10) with 25+ projects; set objectives, provide guidance, evaluate performance
- Review and approve all documents for regulatory filings; INDs, NDAs, special designations, e.g., Orphan, Breakthrough, Fast Track, INN, USAN, annual reports, pediatric, meeting requests and briefing documents
- Successful planning, preparation, submission and support for 8 original INDs in 2023
- Develop best practices and toolkits to ensure quality and consistency throughout organization for regulatory strategist on discovery and development teams
- Drove strategic improvements to enhance operational and organizational efficiencies executed expansion and hiring to accommodate growth.
- Fostered work culture of collaboration and inclusion to increase morale and reduce turnover.
Director, Regulatory Affairs
Alkermes Inc
12.2018 - 08.2021
- Core member of Project Team with responsibility for providing strategic regulatory direction for parenteral fusion protein under clinical evaluation for metastatic solid malignancies. Received Orphan Drug and Fast-Track designations
- Supervision of 2-3 direct reports responsible for day-to-day activities supporting INDs, CTAs and global Phase 1-3 studies
- Developed and communicated regulatory intelligence concerning Health Authority approval trends to Project Team and Senior Leadership
- Provided comprehensive risk assessment profiles for regulated aspects of new drug development
- Support collaboration development with partners by developing and communicating strategies and aligning on such strategies in advance of execution
- Regulatory representative to cross-functional committees for quality improvement initiatives and solutions for operational inefficiencies
- Co-preceptor for corporate sponsored internship program
Associate Director, Regulatory Affairs
Alkermes Inc
12.2016 - 12.2018
- Assisted development of and executed regulatory strategy related to drug development candidates, e.g., for long‐acting injectable version of antipsychotic treatment for schizophrenia and bipolar I disorder, and delayed‐release oral immunomodulatory agent for relapsing forms of multiple sclerosis
- Served as Regulatory Project Lead and primary contact to FDA, EMA and HC for global phase 3 programs including overseeing writing of meeting briefing materials and leading preparation for sponsor interactions at regulatory meetings, e.g., pre‐IND, EOP2, Type C, SPA, pre‐NDS and Scientific Advice
- Coordinated with external organizations; including partners, consultants and vendors to ensure appropriate follow‐up, continued dialogue and fostering of partnership with regulatory agencies in support of regulatory applications and company objectives
- Provided guidance to Project Teams regarding regulatory agency requirements, interpretation of industry guidance and evaluation of impact to assigned programs Managed 1-2 direct reports in timely submission and life-cycle management of applications (IND, CTA, NDA), supplements (sNDA), amendments (DSUR, IMPD, CTA-A, PSP, HEOR), safety reporting and responses to Health Authority/IRB queries (RFI, RFC, Deficiency Letters) involving both domestic and international regulatory agencies according to established standards
Manager, Regulatory Affairs
Alkermes Inc
02.2010 - 12.2016
- Maintained filings throughout product life cycle and completed all necessary notifications, supplements, amendments, labeling changes, listings and yearly reports required for products
- Reviewed sections of regulatory submissions to ensure successful filings, compliance with global regulatory agency requirements, and alignment with company objectives /strategic messaging
- Represented Regulatory Affairs as member of project, clinical development, clinical study, supply chain, labeling, global development strategy and other cross‐functional teams
- Coordinated with internal publishing resources for on time delivery of high‐quality submissions to regulatory agencies
Contractor, Regulatory Affairs
Momenta Pharmaceuticals Inc
03.2009 - 02.2010
- Served as Regulatory Affairs representative on project team for generic version of complex polypeptide mixture indicated for treatment of relapsing‐remitting form of multiple sclerosis
- Managed preparation of submission‐ready documents, including general correspondence, reports and amendments, as well as authoring various sections of submissions as required
- Responsible for coordinating and resolving submission issues interdepartmentally; ensuring compliance with electronic submission document standards; maintaining regulatory contact and submissions log; providing regulatory guidance to various internal project teams
- Liaised with partner companies, external advisors and consultants as needed to ensure full agreement on regulatory strategy
Manager, Regulatory Affairs
Acusphere Inc
07.2005 - 03.2009
- Managed planning, generation, writing and submission of regulatory documentation (IND/NDA), meeting packages (pre‐IND, EOP2, pre‐NDA, Type C) and other communications with FDA for development programs, e.g., cardiac imaging agent and acute pain treatment
- Participated in preparations for Advisory Committee (CRDAC) meeting and pre‐approval inspections of manufacturing facility.
- Served as regulatory affairs representative on project teams
- Reviewed internal technical documentation and deliverables, including CMC, pre‐clinical and clinical protocols/reports for compliance with Agency guidelines
Manager
Chemic Laboratories Inc
07.2003 - 07.2005
Study Director, Toxicology
Springborn‐Smithers Laboratories Inc
09.1986 - 06.2003
Education
MS - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy And Health Sciences
Boston, MABS - Biology
University of Massachusetts
N. Dartmouth, MASkills
- Regulatory strategy
- Critical thinking
- Coaching/mentoring
- Collaboration
- Interpretation/application of regulations
- Cross-functional leadership
- Regulatory submissions
- Intelligence gathering
- Expedited pathways
- Staff supervision
References
Ms. Ann Kurowski (VP Regulatory Affairs, Seres Therapeutics)
USA 978.604.4260
Ms. Aine Miller, Ph.D (VP Regulatory Affairs, Theravance Biopharma)
Ireland +353 86 0476702
Ms. Nannette Hayes (Director Regulatory Affairs, Leap Therapeutics, Inc.)
USA 781.789.4740
Ms. Georgianna Harris, Ph.D (Regulatory Consultant, GSH Consulting, LLC)
USA 781.290.8988
Therapeutic areas
Oncology - solid tumors
Schizophrenia
Bipolar disorder
Multiple sclerosis
Cardiac imaging
Acute pain
Keywords
Small/large molecules
Orphan Drug Designation
Clinical development
Fast-Track Designation
PDUFA meetings
Immuno-oncology
Oncology Center of Excellence
Monoclonal antibodies
Antibody drug conjugates
Bispecific/trispecific antibodies
Timeline
Senior Director, Regulatory Affairs
BeiGene USA, Ltd
01.2022 - Current
Director, Regulatory Affairs
Alkermes Inc
12.2018 - 08.2021
Associate Director, Regulatory Affairs
Alkermes Inc
12.2016 - 12.2018
Manager, Regulatory Affairs
Alkermes Inc
02.2010 - 12.2016
Contractor, Regulatory Affairs
Momenta Pharmaceuticals Inc
03.2009 - 02.2010
Manager, Regulatory Affairs
Acusphere Inc
07.2005 - 03.2009
Manager
Chemic Laboratories Inc
07.2003 - 07.2005
Study Director, Toxicology
Springborn‐Smithers Laboratories Inc
09.1986 - 06.2003
MS - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy And Health Sciences
BS - Biology
University of Massachusetts
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