Associate Ii Reg Cmc Strategy, Si Lcm

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:...

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...

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. ...

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...

Functions as a CMC – Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) to updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received. Other actives may include working with GRS-CMC and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products...

Functions as a CMC– Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) to updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received. Other actives may include working with GRS-CMC and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products in...

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...

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....

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...

Manages the day to day work activities of the team along with the regulatory activities associated with projects assigned to the team and self. Responsible for the deliverables of the team Provides review support and guidance to the team in impact assessment of regulatory changes, preparation of regulatory strategy and supplement/variation authoring. ...

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...

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...

The ideal candidate is a motivated, well-organized individual who has a deep understanding of prospecting and developing strong relationships with customers. . Working experience with national - international OEMs & SI . Working experience in IT industry preferred with memory background . A brief business plan & Strategy with GTM. . For India Local brand...

The ideal candidate is a motivated, well-organized individual who has a deep understanding of prospecting and developing strong relationships with customers. . Working experience with national - international OEMs & SI . Working experience in IT industry preferred with memory background . A brief business plan & Strategy with GTM. . For India Local brand...

The ideal candidate is a motivated, well-organized individual who has a deep understanding of prospecting and developing strong relationships with customers. . Working experience with national - international OEMs & SI . Working experience in IT industry preferred with memory background . A brief business plan & Strategy with GTM. . For India Local...

Job Description JOB SUMMARY: - Managing individual projects of benefit to therapeutic area teams within the group - Support for use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed. JOB SUMMARY: - Author and Maintain Regulatory Product...