Informacje o stanowisku

Regulatory Data and Conformance Manager

Why Patients Need You

Were 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 be part of a team that will guide Pfizer by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures.
• You will find yourself investigating and resolving compliance problems from within Pfizer and outside.
• You will keep the employees aware and knowledgeable about compliance policies by designing various programs.
• You will be relied on to conduct audits, compliance reviews and evaluate current policies, procedures and documentation.
• As a Manager, you will 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 the field of regulatory affairs, 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 dedication 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, plan resource requirements for projects across the division.
• Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies.
• Assess all Quality events received within Worldwide Strategy and Regulatory as described in Quality Management System.

Qualifications

Must-Have

• Bachelors Degree
• 5+ years of experience
• Experience within Pharmaceutical Sciences and/or Good Manufacturing Practices Manufacturing environment
• Proven ability to manage regulatory or drug development issues and consistently deliver to time, cost and quality standards
• Experience in project management through working submission or Chemistry Manufacturing and Control (CMC) change management knowledge gained in Regulatory Operations or Regulatory Affairs
• Knowledge of drug development practice, rules, regulations and guidelines
• Aptitude for customer service, facilitation, problem solving and conflict resolution
• Proven technical aptitude and ability to swiftly learn and apply processes, systems and standards including electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools

Nice-to-Have

• Masters degree
• Relevant pharmaceutical experience
• Demonstrated experience in regulatory affairs or compliance
• Experience working cross-functionally on broad and strategic initiatives

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