Altavis Myers
Morristown
Summary
Experienced regulatory affairs professional with broad experience in both team leadership and project delivery. Excelling in CMC strategy development, regulatory submissions, and risk management. Proven track record in cross-functional collaboration and complex problem-solving to drive efficiencies and compliance in global projects. Skilled in building strong relationships across all levels of an organization to achieve business goals.
Overview
26
26
years of professional experience
Work History
Manager, Global Regulatory Affairs, CMC Pharmaceuticals
BOEHRINGER INGELHEIM
North Brunswick
01.2018 - Current
- Accountable for new products and/or marketed products support as it pertains to the CMC technical section of regulatory filings
- Works in new product development, maintaining approved products, including finished product and drug substance, site transfers and in line extensions
- Prepares and reviews submissions of the CMC section such as full Part 2/CMC Technical Sections (INAD/NADA/MAA’s), variations, supplements, MCSR’s and responses to authorities questions
- Defines Worldwide CMC Regulatory Requirements for changes, including defines CMC strategies, prepares and issues variations and supplements, prepares answers to authority’s requests and/or incomplete letters; identifies relevant experts and/or writes position papers
- Performs EMEA, U.S. and international regulatory research tasks as requested
- Defines Worldwide CMC Regulatory Requirements for manufacturing/analytical site transfers
- Reviews and elaborates templates of CMC documents (manufacturing process validation report, analytical validation report, stability report) in close collaboration with concerned functional areas within Research and Development, Industrial Operations and others as needed
- Identifies potential regulatory issues, recommends actions, obtains managements agreement and executes agreed strategy
- Represents RA on multifunctional teams and functions as privileged contact for Industrial Operations and Quality Assurance
- Establishes and maintains regular exchange with product-responsible RA colleagues in EU/US and international RA
- Assists the country registration managers/distributors/agents and provides them with technical regulatory support required for the CMC/PART II/QUALITY section, appropriately adapted to the specific regulatory requirements
- Maintains an awareness of World Wide regulatory and Pharmaceutical issues and current probable development
Business Owner for Core Lab Systems (CLS Labware LIMS) – Consumer Health R&D
GLAXOSMITHKLINE
Warren
01.2013 - 01.2016
- Managed a team of 36 individuals remotely, across 7 sites globally, to Roll Out a new Laboratory Information Management System (LIMS) for all GSK CHRD sites around the world, thus creating efficiencies and increase in productivity
- Led meetings with CHRD functional heads and stake holders to gather business requirements, communicate and align on development plans and provide updates on progress
- Represented the CHRD Business in cross functional project team meetings with IT and PHARMA partners in the decision making, and approvals for development, validation, implementation and change control activities for the lifecycle of the LIMS system
- Audited established SOPs versus system design capabilities and managed actions from the gap analysis, including establishment of new business practices to create efficiencies using the system, and managing a team of functional experts to author, review and approve SOPs
- Developed a training program that effectively trained over 200 people in the organization, including curricula creation, management of electronic training records and development of an internal website providing links to training materials and Train-The-Trainer protocols
- Authored documents, such as SOPs, validation protocols
- Provided business review and approvals for IT documents and change controls
- Approver for all implementation documents and system notifications to approve the system to go live after each iterative change
Senior Stability & Regulatory Scientist, Global Stability, CHRD
GLAXOSMITHKLINE
Warren
01.2009 - 01.2015
- Represented Regulatory Affairs, specifically in the area of Stability, for GSK consumer healthcare goods, such as Solid Orals Dosage forms, Suspensions, Cosmetics, Nutritionals, Medical Devices, novel delivery systems (such as buccal strips)
- Provided Stability expertise in cross functional project teams to develop submission strategies for expedited approvals
- Designed protocols to generate scientific data to support expiry terms and storage conditions
Manager, WWQ&C-Policies and Compliance Support
BRISTOL-MYERS SQUIBB
New Brunswick
01.2007 - 01.2009
- Managed the WWQ&C Policies and Directives life cycle within the Quality System Framework (QSF)
- Authored policies governing site SOPs based upon harmonized global health authority regulations
- Subject Matter Expert (SME) for the QSF ensuring that sites have guidance to prepare and update their SOPs
- Monitored industry trends to assess impact on the QSF documents and communicated the results to upper management via Corporate Compliance reports with recommended actions
- Monitored emerging regulatory and industry trends in order to assess impact on Policies and Directive
- Coordinated the development of Corporate Compliance reports (such as Global Regulatory Events and Quarterly Compliance reports)
- Created Compliance Reports based upon internal and external GMP inspections and health authority inspections
Senior Stability Scientist, Regulatory Compliance, WWQ&C-Product Manager, Compliance Submission Initiative, Stability
BRISTOL-MYERS SQUIBB
New Brunswick
01.2005 - 01.2007
- Prepared and managed the authoring of the stability sections of the CMC dossiers in the CTD format for Drug Substance and Drug Product for global registrations of BMS products
- Reviewed and commented on CMC dossiers
- Reviewed CMC dossiers for consistency, accuracy and compliance to health authority regulations, applicable guidance documents (e.g., FDA, ICH, EMEA guidance documents), compendial requirements, industry standards and internal standards
- Participated in cross functional teams to communicate issues and accomplish goals related to site stability programs
Senior Stability Specialist/Back-Up Supervisor
SCHERING-PLOUGH (now Merck)
Union
01.2002 - 01.2005
Raw Material QC Analytical Chemist
SCHERING-PLOUGH (now Merck)
Union
01.1999 - 01.2002
Education
Quality Assurance/Regulatory Affairs Certificate -
Temple University
01.2003
Bachelor of Science - Chemistry
Montclair State University
01.1999
Bachelor of Science - Biology
Montclair State University
01.1999
Skills
- Regulatory submissions
- CMC strategy development
- Regulatory compliance
- Cross-functional collaboration
- Complex Problem-solving
- Risk assessment
- Change management
- Decision-making
- Relationship building
- Verbal and written communication
Timeline
Manager, Global Regulatory Affairs, CMC Pharmaceuticals
BOEHRINGER INGELHEIM
01.2018 - Current
Business Owner for Core Lab Systems (CLS Labware LIMS) – Consumer Health R&D
GLAXOSMITHKLINE
01.2013 - 01.2016
Senior Stability & Regulatory Scientist, Global Stability, CHRD
GLAXOSMITHKLINE
01.2009 - 01.2015
Manager, WWQ&C-Policies and Compliance Support
BRISTOL-MYERS SQUIBB
01.2007 - 01.2009
Senior Stability Scientist, Regulatory Compliance, WWQ&C-Product Manager, Compliance Submission Initiative, Stability
BRISTOL-MYERS SQUIBB
01.2005 - 01.2007
Senior Stability Specialist/Back-Up Supervisor
SCHERING-PLOUGH (now Merck)
01.2002 - 01.2005
Raw Material QC Analytical Chemist
SCHERING-PLOUGH (now Merck)
01.1999 - 01.2002
Quality Assurance/Regulatory Affairs Certificate -
Temple University
Bachelor of Science - Chemistry
Montclair State University
Bachelor of Science - Biology
Montclair State University
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