Associate II – Reg CMC Strategy, SI LCM

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...

Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submissions. - Preparation of...

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:...

Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements /...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Responsibility: - Functions as Support to Product Lead for Life Cycle Management (LCM), - working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections for post approval submission. - Responsible for...

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...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

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...

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. ...

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....

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...

Why Patients Need You  We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

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...

A tender or contract is an agreement between the company and an external partner to provide a product at a certain quality, volume and/or price for an agreed upon timeframe. Different organizations such as government agencies, hospitals, insurance companies, etc. are increasingly pursuing tenders to manage cost - All human health products (small molecule and...

Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRS. - Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from...

Work Location Assignment: On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs LI-PFE

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...