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:...

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 and...

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...

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...

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 to...

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...

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...

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...

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...

Why Patients Need YouWe'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 patient...

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

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...

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 contributions...

Why Patients Need YouWe'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 patient...

Why Patients Need YouWe'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 patient...

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...

Associate, Fund/Client Accounting IIJoin an exciting career at BNY Mellon! BNY Mellon offers diverse opportunities in the realms of business, finance, and technology. We are a global leader in asset management and banking, trusted by top financial institutions worldwide to guide them through the digital age.With a rich history spanning many years, BNY Mellon...

Bachelor's degree or Diploma in any discipline. Total 2+ years of experience in IT support domain includes asset management. Hands on experience in Windows. Should be capable to complete the task following the standard operating procedure. Should have experience in understanding IT equipment's, peripherals and IT Warehouse. Should have experience in ewaste...

Associate, Fund Reporting Representative - II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...

Title: Associate Director, Formulation R&DPosition Summary: As the Associate Director of Formulation R&D, you'll spearhead the pre-formulation and formulation design and development processes for pre-clinical and clinical development candidates. This role entails steering the formulation development function, essential for the success of our discovery and...