Principal Manager - Reg CMC Strategy, Vaccines

Job Description

Why Patients Need YouWere 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 vaccines.What You Will AchieveYou will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for large molecule pharmaceuticals/ vaccines to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be in a position to. negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.As a Senior Manager, your advanced knowledge of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for 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.It is your leadership skills that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives. Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures. Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc. Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Essential Health portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision. Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assesses risks and develops contingency plans, including major, complex applications. Execute training related activities {e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums & learning opportunities. Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with Global Chemistry Manufacturing and Controls Principles of Integrity. Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.QualificationsMust-Have Masters Degree 15 years of experience Drug substance or drug product development or manufacturing technical support experience Experience in regulatory Chemistry Manufacturing and Control (CMC) or with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain Good level of knowledge and solid understanding of the development and commercial activities, and (Current) Good Manufacturing Practices (part of GxP) required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s) Ability to learn and navigate tracking/change control systems, and willingness to train and support others in system use Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities Strong interpersonal and leadership skills Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systemsNice-to-Have PhD degree Relevant pharmaceutical/ Vaccines CMC experience Experience managing projects Experience with diverse dosage forms, particularly sterile productsWork 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,

Keyskills :
regulatory affairspharmaceuticalsvaccinesregulatory submissionsleadership skillsproject managementcomplianceproblem solvinginterpersonal skillsMicrosoft Officechemistry manufacturingcontrol