Manager - RegCMC, Medical Devices

Manager - RegCMC, Medical Devices

Use Your Power for Purpose

In an ever-changing regulatory environment, Pfizer relies on a knowledgeable and skilled Regulatory Affairs team. As part of this dynamic team, you will review and interpret increasing regulatory requirements and their associated commercial pressures to ensure the best patient care. Our patients depend on dedicated colleagues like you, experts in your field, who prioritize their well-being above all else. Your work will have a direct impact on ensuring that our products meet the highest standards of safety and efficacy, ultimately contributing to the health and well-being of patients worldwide.

What You Will Achieve

In this role, you will:

• develop effective relationships with local & global internal partners, i.e., R&D (PTx, BTx), PGS, GRS, BU’s, etc.
• Primarily support the maintenance and post-approval changes of Pfizer's on-market portfolio for combination products, ensuring all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
• Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
• Execute training related activities (e.g. compliance-related, HR policies…), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
• Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
• Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Serves as a technical and scientific resource within own work group/discipline of combination products and provides guidance for completion of difficult and complex projects to cross-functional project team(s).
• Serving as the device-focussed CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
• Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects and escalate technical issues and regulatory risks to management as required.

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline (engineering)
• Prior industry working experience in maintenance and management of changes related to Medical Devices and combination products for highly regulated markets such as US FDA, EMA, TGA
• Advanced skills in written & oral communications are mandatory.

Bonus Points If You Have (Preferred Requirements):

• Technical discipline with 6+ years of experience in the pharmaceutical industry with relevant technical experience (Technical Services, Manufacturing or R&D supporting Combination product development or LCM) and 3+ years pharmaceutical regulatory experience.
• Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post approval variations) is preferred.
• Experience operating within GMP, GLP, or GCP related SOPs.
• Product release system exposure helpful
• Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.
• Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products
• Strong understanding of CMC change management processes and CMC CTD content/structure.
• Strong understanding of CMC aspects of combination product development and maintenance.
• Working knowledge and understanding of very relevant ISO standards such as ISO 13485, ISO 14971 and FDA QMSR is highly desirable
• Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
• Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflowtools) and other data management tools
• Prior experience managing projects is preferred.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs

Experience Level

Mid Level