Senior Associate I - Regulatory Change Manager

Job Description

locations India - Chennai time type Full time posted on Posted 5 Days Ago job requisition id hidden_mobile What You Will Achieve You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Partnering with internal and external partners, the incumbent confirms the appropriate components required to support a CMC/Regional change in collaboration with the CMC/Regional Strategist and/or RCM Product Manager, confirms and/or establishes CMC/Regional content provision timelines and subsequently project manages their delivery to the appropriate colleagues. In parallel the incumbent assumes responsibility to assure product compliance through timely and accurate maintenance of CMC/Regional product information in both CMC/DE change management systems and regulatory planning and document management systems.CMC change management/Regional planning and compilation can take place over days, weeks or months from trigger to completion and will involve coordination with others regarding components and standards required for multiple Boards of Health. Multiple CMC/Regional change types at different stages may be managed in parallel, related to product, dossier type or country assignments/requirements.
• Works with colleagues from multiple regions in order to deliver CMC changes that meet the individual national requirements for which the CMC change leading to a BoH submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and United States) along with coordination activities for assigned products and/or at required CMC change management Process as appropriate.
• Enters and maintains critical regulatory information relating to assigned CMC change management activities within required systems and to required standards and timelines.
• Provide operational support within RCM team to execute designated tasks associated with CMC/Regional colleagues.
• Accountable for delivering tasks with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions.
Qualifications Must-Have
• Bachelors Degree in pharmacy, Biotechnology or Science background
• Proven 5+ years experience to working within a tightly regulated environment.
• 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
• In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
• Ability to successfully plan workload against competing priorities.
• Experience with CMC change management processes/systems and CMC CTD content is essential.
• Experience with eCTD publishing, especially Module 3, and workflow management tools
• Good knowledge of English, spoken and written
• Proven technical aptitude and ability to swiftly learn and apply processes, systems and standards including electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools.
Nice-to-Have
• Experience in project management
• Master s degree in pharmacy, Biotechnology or Science background
• Has Fundamental knowledge and skills of regulatory CMC submissions and ensure regulatory or business requirements are fulfilled
• Commit to completing required on-the-job training courses to ensure training compliance is preserved.
• Promotes the use of Document Management systems and standard document publishing processes, partnering with supplier groups as necessary to produce timely delivery of submission ready components.
• Execute regional specific CMC tasks to support on-time project delivery.
• Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigor and risk.
• Command necessary knowledge and skills for on-time delivery of CMC submissions ensuring business requirements are fulfilled.
• Accountable for delivering category aligned submissions with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
Work Location Assignment: FlexiblePfizer 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,

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