Job Description

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 access to Pfizer medicines and vaccines.What You Will AchieveYou will be part of a team that will guide Pfizer by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. You will find yourself investigating and resolving compliance problems from within Pfizer and outside. You will keep the employees aware and knowledgeable about compliance policies by designing various programs. You will be relied on to conduct audits, compliance reviews and evaluate current policies, procedures and documentation.As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Your focus and ability to meet the teams targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.JOB SUMMARYCommitted to quality and excellence in compliance and conformanceAccountable for maintaining the corporate change and dossier management system (PDM) health authorities per internal SOPs and policies.Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.JOB RESPONSIBILITIESCommitted to quality and excellence in compliance and conformanceAccountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.Contributes to the completion of PDM updates independentlyManages own time on deliverablesResponsible for evaluation of all CMC notifications for accuracy.Ensures all the gaps are being addressed in-line with the defined processes and the current regulationsContributes to the deliverables of the complex cases with the guidance of Team Lead / DesigneeApplies technical knowledge and key concepts in Conformance updates.Exercises own judgment utilizing breadth of knowledge and prior work experience, in agreement with TL/DesigneeUses the knowledge to provide ideas towards excellence in the Conformance activitiesProvides guidance to colleagues while handling the complex notifications as neededActs as a technical guide for the colleagues for specific regionsConsidered as a technical SME for selected markets / ProductsPerforms random QC checks to improve the efficiency of the teamSupports in ADHOC activities / Withdrawal activities as necessaryOperate to the highest conformance and quality standardsOperate in line with internal SOPs and policiesAdhere to standard turnaround timelinesEscalate any potential compliance issues to managementLiaise with regulatory colleagues and ensures timely escalations to address the potential issuesProvide input to continuously improve and streamline the processContribute to local and regional regulatory initiatives by establishing a culture aligned with Pfizer values and which supports compliance.Ensures to utilize the internal tracking system efficiently to manage self and contribute to overall metrics management for the team.QUALIFICATIONS / SKILLSTechnical Skills -Knowledge and / or experience in Regulatory / Quality /Compliance any other relevant functions within Pharmaceutical IndustryStrong quality and compliance orientationKnowledge of regulatory practices, rules, regulations and guidelinesDiligence and attention to detailGood communication skillsUnderstanding stakeholder needsStandards, Processes and Policies - General standards, processes and policies of Pfizer/Pharmaceutical IndustryBehavioural/Any other Skills - An assertive, take-charge, results oriented, positive can do attitude, and has sense of urgency as appropiratePreferred Qualification - Masters / Bachelors degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.Preferred Year Of Experience - 6 to 9 yearsType of Experience - Demonstrated regulatory or quality or any relevant experience within a Pharmaceutical / Lifesciences Industry. Proven ability to consistently deliver to high quality standards and timelines.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

Pfizer