Laura Conway
Macungie,PA
Summary
Results-driven Regulatory Scientist with 5+ years of experience within Regulatory Affairs and 20+ years within the pharmaceutical industry. Proven track record of successfully leading cross-functional teams and obtaining health authority approvals for pre- and post-approval variations. Focuses on implementing solutions that simplifies work to facilitate cross-product teams to achieve critical results.
Overview
16
16
years of professional experience
Work History
Associate Principal Scientist, Regulatory Affairs,
Merck & Co., Inc
01.2022 - Current
- Responsible for developing and implementing global CMC regulatory strategies for Pneumococcal Conjugate Vaccines (PCV) in accordance with global regulations and guidance, focusing specifically on shelf-life strategies for V114 and V116.
- Responsible for preparation and submission of CMC dossiers for pre-approval (V117/V118) products. Managed both V117C and V118C Phase 1 IND submissions from authoring to regulatory submission.
- Accountable for delivery of regulatory milestones for moderate to less complex projects through the product lifecycle including the assessment of regulatory success along with risk mitigation measures.
- Partnered with others across the enterprise to develop a business process for high volume stability updates which increased efficiency and capacity for the Regulatory CMC Analytical team.
- Lead the development, communication, lifecycle management and review of the CMC Reg Strategy Document for smaller projects with a strong focus on post-approval shelf-life extensions.
- Supports annual reports, renewals and responses to health authority questions.
- Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data.
- Lead the transition of V114 post-approval shelf-life extension variations to another team member.
- Mentors junior team members, contributing to their professional growth and development.
Sr. Scientist, Regulatory Affairs-CMC
Merck & Co., Inc
12.2018 - 01.2022
- Responsible for developing and implementing global CMC regulatory strategies for RotaTeq in accordance with global regulations and guidance. Was co-product lead for RotaTeq within Regulatory CMC.
- Responsible for preparation and submission of CMC dossiers for pipeline (V590, COVID) products.
- Accountable for delivery of regulatory milestones for moderate to less complex projects through product lifecycle including assessment of regulatory success along with risk mitigation measures.
- Supported annual reports, renewals and responses to health authority questions.
Sr. Scientist, Vaccines and Biologics Stability
Merck & Co., Inc
11.2008 - 12.2018
- Responsible for developing and implementing stability protocols and evaluating stability data for multiple vaccines.
- Investigated atypical and out of specification stability results, and authoring stability sections of regulatory submission documents.
- Developed stability strategies for new products and in-line products undergoing post approval changes and coordinating with labs (including external parties) to ensure successful execution of stability studies.
- Maintained clear and effective verbal and written communication with internal and external customers, participated in cross-functional teams, and facilitated site and divisional stability initiatives.
Education
Bachelor of Science - Chemistry
Albright College
Reading, PA05.1999
Skills
- Strong written and verbal communication
- GMP Compliance
- Regulatory Strategies
- Product Management
Timeline
Associate Principal Scientist, Regulatory Affairs,
Merck & Co., Inc
01.2022 - Current
Sr. Scientist, Regulatory Affairs-CMC
Merck & Co., Inc
12.2018 - 01.2022
Sr. Scientist, Vaccines and Biologics Stability
Merck & Co., Inc
11.2008 - 12.2018
Bachelor of Science - Chemistry
Albright College
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