Regulatory Data and Conformance Manager

ce 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

• Bachelor's 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

• Master's degree

• Relevant pharmaceutical experience

• Demonstrated experience in regulatory affairs or compliance

• Experience working cross-functionally on broad and strategic initiatives

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Regulatory Affairs

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