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 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.

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

• Collaborate with departmental and cross-functional colleagues (eg. G-CMC, GRS, GRO, and PGS) to progress Pfizer’s business objectives, 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.
• Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global medical device, combination product and/or IVD portfolio. Partner with other CMC strategists across the broader CMC organisation in providing continued support and regulatory assessments or developing regulatory strategies with some supervision to development teams and lifecycle programs across the MDCP portfolio.
• Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements projects across the Department.
• 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 working in medical device and combination products, i.e., Quality Assurance, Pharmaceutical Research and Development including Device Centre of Excellence, Pfizer Global Supply - GTEL, Worldwide Safety and Global Regulatory Business Units, etc.
• Leverage both technical and regulatory knowledge, to develop regulatory strategies and mitigate risks.
• Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
• Use technical and scientific knowledge to prepare and manage the appropriate analysis of CMC submission documentation.

Qualifications

Must-Have

• Bachelor's Degree
• Min 5+ years of experience in pharmaceutical or medical device industry
• Min 3+ years of relevant pharmaceutical/medical device/IVD or combination product development and/or manufacturing experience
• Skills and relevant experience that demonstrate 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 product development or manufacturing lifecycle
• Demonstrated commitment to scientific and regulatory integrity, quality compliance
• Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
• Excellent p