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 CentreOne partner's 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 a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical submissions on time. Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams.

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

How You Will Achieve It

• Provide regulatory support to assigned products/teams. Collaborates with senior colleagues and other functional areas to obtain documentation for partners for both U.S. domestic and international regulatory purposes. Seeks expert advice and technical support as required. Ensures accuracy and completeness of all information. Maintains awareness of applicable regulations.
• With guidance, plans and organizes Pfizer CentreOne partner registration packages needed for regulatory agencies in line with local regulatory requirements and guidelines.
• With oversight, serves as a liaison with Pfizer CentreOne partners pertaining to assigned products/teams. Assists in the preparation of partner agency meeting packages and strategies for agency meetings.
• Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Sciences at research and development meetings and presents agreed upon regulatory positions that may impact Pfizer CentreOne partners.
• Responsible for tracking of a partner’s US Annual Report commitments and preparation of summaries in a manner consistent with Pfizer CentreOne practices
• Facilitate the document legalization and translation process as required for a partner’s regulatory application.
• Actively pursue training in technical and personal skills relevant to development and growth within the role

Qualifications & Skills

Problem Solving:

• Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Define and negotiate regulatory strategy with supervision.
• Exercise good judgment within policy and regulations.

Accountability:

• Responsible for tracking and completion of assigned customer registrations activities.
• Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay a customer’s regulatory approval, which can result in missed sales or regulatory action letters
   

Authority to Act:

• Provides daily regulatory support to Pfizer CentreOne partner project teams and senior colleagues with guidance.
• Participates in preparing regulatory strategies. Reviews major submissions, regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution.
• Act independently on most routine issues, make judgment and execute. This accounts for up to or more than 75% of documents/issues handled. Major submissions and strategies are overseen by a manager or senior colleague.

Analytical Ability:

• Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues.
• Presents scientific data effectively orally and in writing in a logical and persuasive manner.

Must-Have

• Bachelor's Degree
• 5+ years of experience
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Strong knowledge of the drug development process, regulatory affairs, and submission management
• Understanding of systems and electronic technologies used to support submission and planning activities
• Attention to detail and exceptional organizational skills
• Presents scientific data effectively, in verbal and written in a logical and persuasive manner
• Proven experience managing or delivering through others in a team environment
• Proficient in English, verbal and written

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Familiarity with pharmaceutical organizational structures, systems, and culture

Other Job Details:

• Last Date to Apply for Job: 4 APRIL 2023
• Eligible for Employee Referral Bonus
• NOT Eligible for Relocation Assistance

Work Location Assignment: Remote

Remote colleagues work from home 5 days a week or are field-based colleagues that are not affiliated with a Pfizer site.

Relocation assistance may be available based on business needs and/or eligibility.