Regulatory CMC Manager

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 a Manager on the Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs team. You will play the critical role of providing strategic product direction to teams while interacting with local country offices and regional hubs to expedite creation and approval of investigational submissions, commercial product registrations and post-approval variations. Based on your expertise, you will be a CMC Strategist on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Acting as a Manager, your advanced knowledge of the principles and concepts in the CMC 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/co-lead complex projects across the Pfizer Inflation & Immunology and Internal Medicine divisions, 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, providing regulatory assessments and developing regulatory strategies with minimal supervision. Lead the preparation of CMC information for submission to regulatory agencies, assess risks and develop contingency plans, especially for major, complex applications. Execute training-related activities (e.g., compliance, People Experience 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 your work group and provide guidance for completion of difficult and complex projects. Qualifications Must-Have BS/BA Degree with 5 years of relevant biologics CMC experience in the industry. Three (3 ) years of experience in a Regulatory Affairs or Quality function in the pharmaceutical industry. Drug substance or drug product development or manufacturing technical support experience Solid understanding of pharmaceutical biologics investigational, development and commercial manufacturing global regulations and activities (Current) Good Manufacturing Practices (part of GxP) understanding and training Ability to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s) Experience, understanding and ability to assess global CMC change controls for potential variation preparation and submission to global health authorities Ability to learn and navigate tracking/change control electronic 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 programs, such as Microsoft Office, Document Management Systems, Trackwise, etc. Nice-to-Have MS/MA/MBA degree 3 years of relevant biologics pharmaceutical industry experience Extensive experience managing projects and working with project teams Experience with diverse dosage forms, particularly sterile products Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. *Last date to apply is February 17, 2023* Relocation assistance may be available based on business needs and/or eligibility. Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Regulatory Affairs #LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.