Responsibilities Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Support for updates in system for License withdrawals Operate in line with internal SOPs and policies Adhere to standard turnaround timelines Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values Assist in ensuring internal regulatory processes and procedures are well documented Assist in remediation activities Support the teams in ADHOC activities Shares the learning time to time with the team colleagues   Qualification & Experience Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. 2 to 4 years of experience  

Responsibilities Calibration of HPLC, Gas Chromatography, Ion Chromatography, AAS, TOC, UV Spectrophotometer, FTIR, Raman, Potentiometer etc. Calibration of Dissolution Test Apparatus, UV Cabinet, Media Degasser etc. Standardization of KF Reagent. Timely completion of performance verification of instruments and equipment. Execution of instrument and equipment qualification protocols. Daily calibration of balances, pH meter, Conductivity meter, Dissolved Oxygen Meter. Preparation of reagents and standardisation of volumetric solutions. Maintenance of spares/accessories of all laboratory instruments and equipment. Reporting of Deviations, Chromatographic Errors and LIR (If any). To follow Good Laboratory Practices and safety policies in the laboratory standard area. To ensure compliance to the policy and procedure requirements on Data integrity. Ensure maintenance of logbooks, Inspection lot number register and all relevant registers in the laboratory.       Qualification & Experience Master’s/Bachelor’s Degree in Chemistry or equivalent degree 1-3 years of experience in Non-Routine section and calibration of laboratory instruments and equipment.  

Responsibilities You'll be responsible for managing artwork projects, interacting with Marketing Companies, graphic design studios, internal functions within AZ and Contract Manufacturers. You'll act as the primary point of contact for globally-located suppliers and customers to coordinate artwork changes and will be confident in managing competing demands. You'll also agree and embed processes and ways of working with new suppliers in the AstraZeneca artwork management system ensuring full compliance with labelling business processes and SOPs.   Qualification & Experience A degree (or equivalent qualification) in business, supply chain, engineering or any scientific discipline is preferred, equivalent experience will be considered Experience of working in Sharepoint Experience and knowledge of project or change coordination/management Experience of delivering projects in a matrix environment Experience and understanding of pharmaceutical packaging artwork/labelling management Experience of Lean and good problem-solving ability Experience of working with regulatory and GMP requirements Strong and clear communication skills Proactive approach Experience of working in a GMP change management system  

Responsibilities Contribute to the completion of project milestones and organize own work to meet project task deadlines. Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations. Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level. Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience. Support the regulatory activities associated with allocated new food supplements in development. Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal. Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice. Communicate with internal team members about execution and strategy as needed Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role. Act as a subject matter expert on global regulatory requirements in the cross functional team.     Qualification & Experience Bachelor's Degree Demonstrated experience Relevant experience in electronic submissions build within the Pharmaceutical Industry Demonstrated coordination of activities in a highly regulated environment Demonstrated experience working in a challenging customer service environment Knowledge of the drug development process  

Responsibilities Coordinate and contribute to the definition of assigned product area Drive ongoing backlog allocations and prioritization of customer jobs to solve within area of responsibility Define epics and user stories, clearly articulating business requirements for the problems we are aiming to solve - including UX/CX/Support requirements Identify and track metrics and success criteria to create transparency and visibility to program success and opportunities for improvement – Requesting analyses to inform backlog Partner with Product Management leaders to be the voice of product decisions within the organization Represent the customer for assigned product area, demonstrating responsibility for end-to-end customer journey and touchpoints Cross-Functional Coordination and Stakeholder Management Serve as Product Owner for scrum teams covering assigned product area Partner with Product Management leaders to drive portfolio and product strategy Support feature rollouts through alpha, beta and general availability by collaborating with customer-facing teams, analyzing feature impact, and preparing communications Engage with Sales, AM, Product Marketing, and other internal partner teams as needed to determine best ways to communicate product to customers; and to assist Product Management leadership with service descriptions Contribute to the development of overall product management team by lending your knowledge and experience to teach others what you know       Qualification & Experience Bachelor’s Degree or equivalent experience in Product Management 7+ years of product management experience Prior experience with working on healthcare/healthcare interoperability (integrations/HL7/CCDs/Interface Engines) is a plus  

Responsibilities Monitor and leverage Risk Based Analytics to execute on Case Quality Audits Provide feedback and coaching to agents regarding Case interactions Work in collaboration with teammates across geographies to review chatter feedback submitted to CCQ Chatter Group Champion Knowledge article usage and education to support self-service and first contact resolution Collaborate with managers regarding agent trends and recommendations for improvement Provide real-time Coaching through Integrated/Live Monitor Support Leverage quality dashboards to perform data analysis for top trending questions and parameters to identify coaching packages and plans to deliver to agents to drive improvement Prepare and deliver post-training nesting period support for new content trainees (If required) Collaborate with Customer Care Quality Teammates, ICM’s and Enablement & Effectiveness Org. Leadership across geographies to provide statistical and anecdotal insights to drive the curation and creation of collateral and training modules Leverage technology platforms (NICE, OneNote Coaching Toolkit) to enable agent and client success; offer recommendations and additional use cases for expanded impact of resources Calibrate amongst teammates and across geographies to drive accuracy and consistency within quality forms and chatter reporting   Qualification & Experience Bachelor’s degree preferred or 2+ years of equivalent industry experience Foundational Knowledge and/or mastery of athenahealth products Proficiency in Microsoft teams, Outlook, Word, Excel, and PowerPoint  

Qualification & Experience 2-15 Years in Pharmaceutical industry with major experience in Global Regulatory Affairs function. Authoring and/or contributing line to CMC content for New Development & Post-approval Variations/ Supplements for Chemical Entities, Biologicals, Vaccines (INDs/ IMPDs/ NDAs/ BLAs/ ANDAs/ MAAs/) & Medical Devices (PMA/ 510(K)/ Notified bodies/ Design History File) for Global markets. Candidates with relevant technical experience in Pharma R&D, Tech Transfer, Quality & Manufacturing, aspiring for Regulatory role can also apply, and will be considered based on fitness and potential.    

Responsibilities Committed to quality and excellence in compliance and conformance. With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Operate in line with internal SOPs and policies Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Assist in remediation activities     Qualifications & Experience Bachelor's Degree Demonstrated experience Proven ability to consistently deliver to time, cost and quality standards Operational knowledge of hardware and software tools required for the job Excellent organizational skills and attention to detail Knowledge of documentation practices Fluent in English, verbal and written Project Management experience Knowledge across multiple therapeutic areas

Responsibilities 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 / variations for LCM submissions and ensures effective data presentation and quality, by self or under guidance. Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of  supplements  to ensure effective data presentation and quality. Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (batch records, Exhibit batch and stability protocol). Provides regulatory assessment and supports Change Control Assessment, by self or under guidance. Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate. Provide regulatory support for the assigned products, participates and provides inputs in technical reviews and Change Control reviews as assigned.   Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, Team lead and core team. Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects. Responsible for ensuring compliance to Company’s submission standards, policies and procedures.     Qualifications & Experience Bachelor's Degree 3+ years of demonstrated experience in regulatory affairs or in a regulated industry Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards In-depth knowledge of the current health regulatory framework for drug regulatory procedures Problem solving skills, strong detail, quality and compliance orientation Good verbal and written communication skills and fluent in English Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use Master's degree Relevant pharmaceutical experience Strategic thinking with good project management skills  

Responsibilities Ensures effective coordination and collaboration with GRS-CMCs and the regional regulatory leads to ensure key submission deliverables for the assigned projects to the team. Responsible for end to end CMC contribution for the assigned projects; Reviews the assigned regulatory activities including the related technical/supportive information/ documents for completeness and accuracy; Responsible for development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC; Responsible for authoring and/or compiling Regulatory Strategy Documents (RSD) where needed; Responsible for authoring of CMC content in Module 1, Module 2.3, M3.2.S/P/R as agreed upon with the GRS CMC within agreed timelines. Responsible for identification and communication of identified risks to the GRS CMCs and/or appropriate leadership, also proposes mitigation strategy with the support of team lead; Ensures resolution of issues and manages regulatory risks within project. Reviews and applies pertinent global regulatory guidelines. Exhibits technical / functional expertise and provides strategies on regulatory requirement, negotiates with and influences the cross functional teams, colleagues and external partners to ensure regulatory data requirements are met. Coordinates with the respective team for M3.2.R Ancillary documents Represents HBU GRA CMC point of view and meets with key stakeholders to resolve challenges. Coordinates internal document review and sign off. Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate. Supports Query and/or commitment management in collaboration with GRS CMCs. Maintains conformance systems maintenance in support of the GRS CMCs