Job Description

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 us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of project milestones and organize own work to meet project task deadlines.
• Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
• Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
• Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience.
• Support the regulatory activities associated with allocated new food supplements in development.
• Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.
• Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
• Communicate with internal team members about execution and strategy as needed
• Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role.
• Act as a subject matter expert on global regulatory requirements in the cross functional team.

Qualifications

Must-Have

• Bachelor\'s Degree
• Demonstrated experience
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Demonstrated coordination of activities in a highly regulated environment
• Demonstrated experience working in a challenging customer service environment
• Knowledge of the drug development process
• In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation
• Good knowledge of English, spoken and written

Nice-to-Have

• Experience in project management

Job Responsibility

• Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
• Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
• Delivery of Product License Support Portfolio in a timely and quality manner.
• Contributes to the completion of project tasks and/or milestones
• Organizes own work to meet project task deadlines
• Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
• Has fundamental knowledge of the principles and concepts of the discipline.
• Applies technical skills to achieve assigned tasks
• Contributes to the completion of routine Work Team related tasks.
• Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
• Applies fundamental knowledge of the relevant regulatory industry and local business environment.
• Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
• Makes decisions that require choosing between limited options toresolve problems basic in their complexity
• Performs work in a structured environment under direction from supervisor
• Decisions impact own work and have limited effect on projects.
• Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
• Exercises judgment to complete assigned tasks and has significant reliance on supervisor
• Works in a structured environment under direct supervision
• Uses established procedures to perform assigned tasks
• Asks for guidance from other colleagues
• Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
• Communicates straightforward information, asks questions and checks for understanding
• Participates and contributes as a team member
• Is responsible for certain team deliverables

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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