Mary Proctor
Leola,PA
Summary
Results focused and detail oriented professional with experience working in the global pharmaceutical company, with multiple manufacturing sites and regulatory authorities worldwide. Understanding of FDA, ICH and other regulatory CMC requirements through clinical, post approval and life-cycle of the product. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level.
Overview
23
23
years of professional experience
Work History
Associate Director- Regulatory Affairs, CMC
Janssen Research & Development, Johnson & Johnson
Chesterbrook, PA
04.2015 - Current
- Develop effective CMC regulatory strategies for global submissions knowing lifecycle of drug product from clinical through commercialization and interpret and apply local regulations and guidance's to life-cycle of drug product.
- Provide regulatory CMC support for clinical development for monoclonal antibodies, CAR-T and gene therapy products and interface with Pharmaceutical development, project management, operations, supply chain, quality and regulatory colleagues. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.
- Oversee CMC documentation preparation for regulatory CMC dossiers for submission to Health Authorities including preparation of responses to questions from Health Authorities.
- Provide CMC Regulatory support to pre-approval and GMP inspections.
Manager-Regulatory Affairs, CMC
Janssen Research & Development, Johnson & Johnson
Malvern, PA
03.2010 - 04.2015
- Manager-Regulatory Affairs, CMC
- Responsible to review regulatory guidelines and develop formats and global strategies for large molecule post approval submissions.
- Responsible for coordination, preparation review and/or approval of Chemistry, Manufacturing and Controls (CMC) regulatory sections of initial marketing applications, post approval submissions for assigned marketed biological products, including amendments, supplements, variations, notifiable changes, responses to health authorities, etc.
- Provide oversight of routine interactions with health authorities and serve as primary liaison for those interactions. Act as liaison with marketing partners and manufacturing regarding CMC issues.
- Maintain principal responsibilities for day-to-day activities related to assigned marketed biological products projects to ensure regulatory compliance and achievement of organizational goals and timelines as they relate to CMC issues.
- Responsible to maintain good working knowledge of FDA/Canadian/International regulations, GMPs and CMC experience in regulatory affairs.
Senior Regulatory Associate
Janssen Research & Development, Johnson & Johnson
Malvern, PA
03.2005 - 03.2010
Quality Engineer II and II
Centocor Ortho Biotech, Inc, Johnson & Johnson
Malvern, PA
07.2002 - 03.2005
Manufacturing Technician
Wyeth-Ayerst Pharmaceuticals
Marietta, PA
01.2000 - 07.2002
Education
No Degree - Biology
East Stroudsburg University
East Stroudsburg, PABachelor of Science - Biology/Psychology
Long Island University, Southampton
Southampton, NY12.1995
Master of Science - Regulatory Science
Johns Hopkins University
Baltimore, MD 08.2022 - Current
Skills
- Highly motivated individual who provides strategic regulatory expertise
- Proven leader and excellent communicator recognized for ability to establish and maintain effective working relationships across cross-function teams and diverse individuals at any level
- Experience in submitting marketing and clinical CMC applications
- Clinical and post approval experience
- Experienced in Trackwise, RIMdocs, InSight, and RIACs
- Experience with HA meetings and HA inspections
Accomplishments
- Regulatory Affairs Professional Society Dual Certification Program (Medical Device and Pharmaceuticals)
- Completion of the Regulatory Affairs Innovate Program
- Mentor for a Veteran reentering the workforce through the American Corporate Partners (ACP)
- Member of Citizens' Climate Lobby, climate change organization focused on national policies to address climate change.
Affiliations
Drug Information Association (DIA)
Regulatory Affairs Professional Society (RAPS)
Veterans Leadership Council (VLC)
Timeline
Master of Science - Regulatory Science
Johns Hopkins University
08.2022 - Current
Associate Director- Regulatory Affairs, CMC
Janssen Research & Development, Johnson & Johnson
04.2015 - Current
Manager-Regulatory Affairs, CMC
Janssen Research & Development, Johnson & Johnson
03.2010 - 04.2015
Senior Regulatory Associate
Janssen Research & Development, Johnson & Johnson
03.2005 - 03.2010
Quality Engineer II and II
Centocor Ortho Biotech, Inc, Johnson & Johnson
07.2002 - 03.2005
Manufacturing Technician
Wyeth-Ayerst Pharmaceuticals
01.2000 - 07.2002
No Degree - Biology
East Stroudsburg University
Bachelor of Science - Biology/Psychology
Long Island University, Southampton
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