Open To Work
Amy Martin
Morgantown,WV
Work Preference
Summary
Dynamic professional with 29 years of combined pharmaceutical industry experience in both Regulatory Affairs and Analytical Research and Development. Proven track record in relationship building, strategic planning, and operational efficiency. Expertise in developing high-performing teams and driving initiatives for successful market launches and continued product availability.
Overview
29
29
years of professional experience
Work History
Senior Regulatory Affairs Director
Viatris
Morgantown, WV
12.2019 - 08.2026
- Led my teams to optimize and implement strategies to ensure timely market launch.
- Developed and implemented regulatory strategies for submitting complex change proposals to the US FDA.
- Acted as a project manager to maximize efficiency across multiple departments.
- Developed detailed project plans based on broad guidance from executive leadership.
- Facilitated cross-functional collaboration for improving decision making and project deadlines.
- Established relationships with regulatory agencies to facilitate communication and approvals.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Optimized staff performance by designing comprehensive training programs.
- Attended conferences and forums to maintain current knowledge of industry related topics.
Regulatory Affairs Consultant
Martin Pharma Consulting, LLC
Morgantown, WV
01.2018 - 11.2019
- Led regulatory submissions for drug approvals, ensuring compliance with US FDA standards.
- Developed and implemented regulatory strategies to optimize approval timelines for clients.
- Conducted comprehensive reviews of regulatory documents to ensure accuracy and completeness.
- Managed complex regulatory projects, consistently meeting critical deadlines.
Director of Regulatory Affairs
Viatris
Morgantown, WV
03.2013 - 03.2017
- Led regulatory submissions to ensure compliance with global health authority requirements.
- Prepared and maintained document inventory for core dossier preparation.
- Reviewed technical documentation for accuracy and adherence to regulatory guidelines.
- Coordinated cross-functional teams to streamline regulatory approval processes.
- Established relationships with regulatory agencies to facilitate communication and approvals.
- Approved change proposals and developed strategies for minimizing market disruptions.
Manager of Regulatory Affairs
Viatris
Morgantown, WV
03.2010 - 03.2012
- Provided assistance to senior leadership in Regulatory Affairs to prepare new product dossiers.
- Prepared regulatory submissions (amendments and post approval supplements) for new product approvals and post approval activities by ensuring compliance with health authority requirements.
- Reviewed and approved product annual reports for consistency and compliance.
- Prepared technical documentation to support transfer activities between RD and Quality at time of product launch.
Senior Regulatory Affairs Specialist
Viatris
Morgantown, WV
03.2006 - 03.2010
- Reviewed product change proposals against industry regulations and guidance documents.
- Provided reporting category recommendations for change controls initiated by QA, QC, Sourcing and Tech Support departments.
- Prepared annual reports.
- Assisted Regulatory Affairs leadership in the preparation of post approval supplements.
Manager of Analytical Research and Development
Viatris
Morgantown, WV
03.2002 - 03.2006
- Managed a team of seven (7) in the HPLC method validation space.
- Approved documentation (i.e. analytical specifications, test procedures and method validation reports) intended for regulatory submission.
- Provided support to Regulatory Affairs leadership to author narratives intended for inclusion in new ANDAs and subsequent amendments.
Analytical Chemist
Viatris
Morgantown, WV
05.1997 - 03.2002
- Performed analysis of pharmaceutical finished products using various methods to test for purity.
- Validated analytical methods for pharmaceutical products ensuring compliance to regulatory standards.
- Conducted stability studies to assess product integrity over time, optimizing formulations for enhanced performance.
- Collaborated with method development teams to troubleshoot analytical issues.
- Participated in analytical method transfers between RD and QC to prevent operational delays.
- Trained junior chemists on laboratory techniques and instrument operation, fostering knowledge transfer and skill development.
Education
Bachelor of Science - Chemistry
Waynesburg University
Waynesburg, PA05-1997
Skills
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
Timeline
Senior Regulatory Affairs Director
Viatris
12.2019 - 08.2026
Regulatory Affairs Consultant
Martin Pharma Consulting, LLC
01.2018 - 11.2019
Director of Regulatory Affairs
Viatris
03.2013 - 03.2017
Manager of Regulatory Affairs
Viatris
03.2010 - 03.2012
Senior Regulatory Affairs Specialist
Viatris
03.2006 - 03.2010
Manager of Analytical Research and Development
Viatris
03.2002 - 03.2006
Analytical Chemist
Viatris
05.1997 - 03.2002
Bachelor of Science - Chemistry
Waynesburg University