Job title: Principal Manager, TAPS
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 represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports. As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division. It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Develop ideas and lead projects across the division and develop plans to achieve objectives. Develop regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variationsand lifecycle management. Provide strategic contribution to the country or cluster markets that give support leadership team. Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders. Maintain licenses in compliance with local regulations of the countries by ensuring that corporate regulatory processes,Standard Operating Procedures (SOP)and systems are in place, also ensure team is properly trained in these systems and procedures. Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and SOPs. Implement systems, processes and procedures relating to regulatory strategy productivity improvements, ensure that these facilitate share information across the relevant lines. Deliver project /product strategy including label and risk assessment for assigned projects/product. Ensures business compliance and implementation of and adherence to Regulatory standards. Develop and enhance relationships with key external agencies, strong partnerships with in-country or cluster markets that give support to facilitate the development and implementation of registration strategies. Qualifications Must-Have Bachelor’s Degree(BA/BS)and 9+ years of experience. Knowledge of the Regional and Global regulatory environment. Knowledge of drug development practice, rules, regulationsand guidelines. Understanding of business andfinancialenvironment. Nice-to-Have Master’s degree(MA/MBA/MS)and 7+ years of experience. Doctorate(PhD/PharmD/JD)with 4+years ofexperience. Thinks strategically with good project management skills. Ability to manage multiple projects, create and manage project timelines. 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: Mon, 27 Dec 2021 23:15:53 GMT
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