Manager Regulatory CMC Strategy
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 help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small molecule pharmaceuticals and potentially devices 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 (clinical), commercial (registration) 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 Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the Department.
- 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.
- Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
- Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions along with prioritizing assigned workload appropriately.
- Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
- Develop effective relationships with local and global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
- Leverage both technical and regulatory knowledge, to mitigate risks.
- Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
- Use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
- Bachelor's Degree
- Proven relevant experience
- Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience
- Demonstrated commitment to scientific and regulatory integrity, quality compliance
- CMC (Chemistry Manufacturing and Control) regulatory and quality expertise to prepare regulatory assessments, develop and contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle
- Excellent planning, organizational and project management skills
- Advanced skills in written and verbal communications
- Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems
- Master's degree
- Relevant pharmaceutical experience
- Experience in R&D/ Quality/technical areas