Manager, CMC
- China - Beijing - Beijing
Job Summary
Collaborate with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
Delivery of high quality regulatory submissions.
Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.
Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
Leverage both technical & regulatory knowledge, to mitigate risks.
Execution of regulatory policies and operational processes.
Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
Job Responsibilities
Responsibilities include:
Serve as a primary CMC representative on a core project(s) and provide CMC support for products at various stages including clinical trial application, NDA and post approval variations
Ensure high quality CMC submissions in compliance with China regulations and guidelines. Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Manage regulatory issues, maintain submission information in relevant GRS-CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
Manage and Contribute to GRS-CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
Demonstrate 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 GRS-CMC Principles of Integrity.
Develop effective relationships with local & global internal partners, e.g. GRS-CMC, China RA, DC and PGS.
Technical Skill Requirements
Technical and/or other job-related skills:
An understanding of China, US and EU regulatory requirements & expectations and criteria for submission & approval globally.
The background of regulatory CMC for supporting therapeutic biologic products and vaccines is preferred.
Demonstrated commitment & dedication to scientific & regulatory integrity & qualitycompliance.
Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
Sufficient level of knowledge in development & commercial activities and cGMP’s is required.
Good skills in written & oral communications in both Chinese and English are mandatory.
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, Documention, dossier workflow tools) and other data management tools
Qualifications (i.e., preferred education, experience, attributes)
Education:
· BS, MS or PhD degree in biotechnology, chemistry, or related scientific disciplines; Advanced degree is preferred.
Experience:
· Technical discipline with 5+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 2+ years pharmaceutical regulatory experience are desired.
Desired / Required Competencies:
Decision Making
· Acts Decisively
Risk Mgt
· Ability to recognize risks across projects and programs.
· Manages regulatory risks & ambiguous situations under direct supervision.
Scientific & Regulatory Leadership
· Ability to contribute to projects or team initiatives to support short-term operational goals.
· Ability to influence at the work group project team level.
Teamwork/ Collaboration
· Ability to contribute to effective teams & implement change.
Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.
Communication
· Communication & Negotiation skills
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)