Job title: CDM Data Sr. Associate
Job description: Job Description : 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 env
Job Description : 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 patient access to Pfizer medicines and vaccines. What You Will Achieve You 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 team’s 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. How You Will Achieve It Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team. Provide support during internal and external audits and ensure all corrective actions are addressed as per designated timelines. Support Regulatory area to review product portfolio data management in systems and databases, in order to keep processes and data in compliance according to Pfizer standards and operate to the highest conformance and quality standards. Compile and prepare materials for submission to regulatory agencies and third party evaluators. Update regulatory electronic systems and tools to share accurate regulatory information with local and above country areas. Liaise with regulatory colleagues to communicate and resolve potential issues. Support audit as part of regulatory data and system scope. Maintain timeliness/ accuracy in the data entry and removal of workload associated with data entry from Regulatory Strategy teams. Manage compliance activities with coordination of information in support of New Drug Application Annual Reports and New Drug Application Periodic Reports. Maintain the corporate change and dossier management system regarding the status of regulatory Chemistry Manufacturing and Control (CMC) submissions with global health authorities per internal Standard Operating Procedures (SOPs) and policies for Pfizer Essential Health (PEH) products. Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility. Qualifications Must-Have Bachelor’s Degree 3+ years of experience Demonstrated success in effectively managing and optimizing standards in regulatory information systems In-depth knowledge of the current health regulatory framework for drug regulatory procedures Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation Quality focus and ability to work with accuracy and attention to detail Good communication skills Nice-to-Have Master’s degree Relevant pharmaceutical experience Experience with Consumer Healthcare products Pfizer 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
Location: Chennai, Tamil Nadu
Job date: Thu, 20 Jan 2022 23:19:47 GMT
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