St-Lazare, Québec firstname.lastname@example.org
Detail-oriented and highly analytical CMC Regulatory Author/Strategist coupled with solid Quality Assurance and Quality Control skills in commercial and clinical environments of the Pharmaceutical industry. Leveraging 20 years of experience ensuring quality and compliance to GMP requirements. Brings forward proven ability to manage multiple project priorities simultaneously to meet deadlines in a fast-paced environment. Excellent oral and written communication skills in French and English. Key Strengths: Quality Assurance Quality Control Documentation Management
Pharmaceutical Product Registration Good Manufacturing Practices CAREER HISTORY
Pfizer Canada Inc., Consumer Regulatory 2012-2018
As the CMC project manager, analyzed and interpreted regulations to determine the CMC regulatory filing requirements for registration of Pfizer Consumer Healthcare commercial vitamin and drug products in over 25 countries based on product classification (Drugs, OTC, Health Products, etc.).
Developed global filing strategies and authored required submission ready components in CTD format for Modules 2 and 3 to support submissions at various stages of the product’s lifecycle including initial registrations, post-approval variations, renewals and annual reports.
Delivered quality CMC registration dossiers for the simultaneous launch of 4 new Centrum products containing approximately 20 active ingredients in over 25 markets collaborating closely on cross- functional teams with Quality Assurance, Technology and other Regulatory departments.
Maintained compliant registration dossiers in various markets for an Advil product through successful filings such as NDA Annual Reports, Canadian Annual Notifications, Colombia product renewal and eCTD baseline for Bahrain.
Registered post-approval changes globally reducing production cost and enabling greater flexibility.
Managed queries from FDA, Health Canada and other Board of Health Regulatory Authorities with 0 rejections.
Pfizer Canada Inc., Worldwide Research & Development 2005-2011
(Previously Wyeth Pharmaceuticals Inc.)
Quality Specialist, 2007-2011
Solely responsible for the release of all incoming materials (raw materials, bulks, packaging components, etc.) for on-time use in clinical trial production.
Chantal Farley email@example.com Page 2
Ensured compliance of internal and manufacturer documentation to GMP requirements
Managed incoming requests during FDA, Health Canada and corporate audits. Delivered prompt and accurate responses generating positive feedback from the auditors and no major observations.
Supervised the workload of two off-site Quality Specialists responsible for retrospectively loading incoming documentation into GDMS, the global document management system, substantially reducing the time required to perform the release of materials.
Created a training aid to clarify the release process for incoming bulk materials thereby significantly improving the uniformity and compliance of the department.
Facilitated a cross-functional team meeting to promote the consultation of the commercial side’s supplier qualification system when selecting new suppliers significantly diminishing the frequency of supplier qualifications required.
Investigation Officer, 2005-2007
Led, commented and managed laboratory, manufacturing, packaging and distribution investigations to ensure the release of compliant materials while meeting investigation and material release due dates also generating positive comments from corporate and Health Canada auditors regarding the quality of investigations.
Investigated and authored responses to customer complaints improving customer relations.
Reviewed and closed audit commitments as appropriate to maintain compliant status.
Performed internal audits and participated in audits from regulatory agencies and corporate auditors. Material Compliance Specialist
EDUCATION and PROFESSIONAL DEVELOPMENT
Bachelor’s Science, Honours Chemistry (Specialty Analytical Chemistry), Institute for Cooperative Education, Concordia University
Introduction to Pharmaceutical Regulatory Affairs Certificate, Academy of Applied Pharmaceutical Sciences
Bilingual in French and English