Manager Regulatory CMC Strategy

Pfizer

Kildare, Cork or Dublin, Ireland

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and 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, 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 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.

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

Qualifications

Must-Have

Bachelor's Degree
5+ years of 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