Associate- I Reg 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 documentation and...

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:...

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...

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...

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...

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...

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...

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 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...

ROLE SUMMARYROLE RESPONSIBILITIES Auditing (verifying) of data and information against source documents and data systems for completeness and accuracy. Perform data verification of Biologics License Applications, Investigational New Drug Applications and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures. Perform data...

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...

With campuses in Austin & Chennai, Illumine Industries Pvt. Ltd. (Illumine-i) is a young multinational firm engineering sustainable living solutions. We are a team of Engineers and creative thinkers, working towards the development of renewable power plants, energy-efficient buildings with competent construction methodologies, clean transportation, and...

With campuses in Austin & Chennai, Illumine Industries Pvt. Ltd. (Illumine-i) is a young multinational firm engineering sustainable living solutions. We are a team of Engineers and creative thinkers, working towards the development of renewable power plants, energy-efficient buildings with competent construction methodologies, clean transportation, and...

Associate_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 "bank of banks" - 97% of the world's top...

The Labeling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and...

About this role:Wells Fargo is seeking a Financial Accounting AssociateAbout Wells FargoAbout Wells Fargo IndiaWells Fargo India enables global talent capabilities for Wells Fargo Bank NA., by supporting over half of Wells Fargo's business lines and staff functions across Technology, Business Services, Risk Services and Knowledge Services. We are operating...

ExternalJob Title:Senior Manager/Associate Divisional Manager/Divisional Manager - Product Planning & StrategyWork LocationOragadam plant, Chennai.Role Reporting mapped to:Associate General Manager/General Manager – Product Planning & Strategy.Job PurposeDefine Product Roadmap for DICV Product Portfolio to ensure competitiveness and profitability,...

About this role: Wells Fargo is seeking a Financial Accounting AssociateAbout Wells Fargo Wells Fargo & Company (NYSE: WFC) is a diversified, community-based financial services company with $2.0 trillion in assets. Founded in 1852 and headquartered in San Francisco, Wells Fargo provides banking, insurance, investments, mortgage, and consumer and commercial...

Associate, Client Service Representative I_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 "bank of...

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...