Manager - Reg CMC Strategy, Brands CMC

Has comprehensive knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to : Manages the day to day work activities associated with assigned renewal applications within agreed upon timelines. Utilizes Pfizer’s systems, i.e. PEARL, GDMS, PDM, SPA, etc., as appropriate....

Role Summary - Support Product Leads develop CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting PBG products registered and marketed within the Asia Pacific (APAC) or Africa and Middle East (AfME) or European Union (EU) region, with supervision. - Provide operational...

• Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS. • Global regulatory strategy development in collaboration with the CMC GRS. • Liaise with Pfizer Global Supply and other support functions as needed. • Use of regulatory systems and management of CMC...

• Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS. • Global regulatory strategy development in collaboration with the CMC GRS. • Liaise with Pfizer Global Supply and other support functions as needed. • Use of regulatory systems and management of CMC...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists –CMC (GRSs-CMC) under the guidance of the team lead. The...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...

Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines. - Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL. - Authors and/or compiles CMC...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post - approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post - approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee. Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited to: - Authors and/or compiles CMC contributions for renewals, i.e. Module 1,...

Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS.- Global regulatory strategy development in collaboration with the CMC GRS.- Liaise with Pfizer Global Supply and other support functions as needed.- Use of regulatory systems and management of CMC documentation...

Role Summary: Functions as the CMC author & strategist for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigned projects and activities, completing work within assigned product...

Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS. - Global regulatory strategy development in collaboration with the CMC GRS. - Liaise with Pfizer Global Supply and other support functions as needed. - Use of regulatory systems and management of CMC documentation...

Functions as Regulatory support for CMC Devices team to support the device programs and life-cycle management (LCM) regulatory activities. The responsibilities as an individual contributor include but not limited to supporting the - Maintenance of the expansive combination of CMC product information, market registration details, component level dossier...

Functions as Regulatory support for CMC Devices team to support the device programs and life-cycle management (LCM) regulatory activities. The responsibilities as an individual contributor include but not limited to supporting the - Maintenance of the expansive combination of CMC product information, market registration details, component level dossier...

Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...

Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...

Functions as Regulatory support for assigned projects and the life-cycle changes; works with Project Leads/Product Leads, cross-funcational teams, local and regional regulatory colleagues, external partners (in-licensed products) and Global Health Authorities (if required) to independently frame and drive global regulatory strategies for post approval...

Functions as Regulatory support for Biosimilars and Biologics development projects and the life-cycle changes; works with Project Leads/Product Leads, cross-funcational teams, local and regional regulatory colleagues, external partners (in-licensed products) and Global Health Authorities (if required) to independently frame and drive global regulatory...

Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines. - Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed. - Performs Market Impact Assessment (MIA) for the specific entity name change. - Runs the Regulatory Requirement Manager...