Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective regulatory strategic team. You will work with GRA oncology colleagues supporting key regulatory tasks and deliverables across programs for regulatory affairs, starting with US regulatory region. Support implementation activities of regional regulatory and labeling strategies in agreement with Global Regulatory Lead (GRL) and other key stakeholders for assigned projects/products.

You will be accountable for timely preparation and, submissions of program(s) deliverables in the US to obtain regulatory approvals, accountable for ensuring optimal regulatory interactions with FDA in relation to the assigned project(s) in US. This Role can be combined with other GRA function activities based upon priorities and project(s) assigned can be in early development/registration and/or at post-authorization stage across oncology.

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 deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between 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

• Ensure regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers, intelligence) for assigned project(s) across categories.
• Work across programs to support IND preparation and submission activities, regulatory systems updates and compliance, regulatory correspondence archiving, rapid response team activities
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.
• Partner with project teams and other customer groups (e.g., RU/BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, IND, NDA/BLAs, etc) meet business needs and are provided to the project teams, to agreed time and quality standards.
• Ensures US regulatory plans are monitored and progress/variance communicated to GRL as well as any risks (from emerging technical data, changing internal objectives or external threats) to be mitigated
• Contribute to develop and achieve alignment on the US regulatory positions for any key issues for assigned projects by closely working with GRL and relevant Team members.
• Ensures business compliance and implementation of and adherence to Regulatory standards
• Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region

QUALIFICATIONS

Must-Have

• BA/BS required
• Knowledge of drug development practice rules, regulations and guidelines - familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
• Career aspiration in developing and implementing regulatory strategy – Basic understanding of regulatory agency philosophy and guidelines.
• Understanding of key concepts of product label aligned to target product profile and corporate expectations.
• Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.
• Negotiation skills - Can negotiate skillfully and diplomatically in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations

Nice-to-Have

• PharmD / PhD / MSc preferred
• Oncology regulatory experience and/or internship preferred
• Experience preparing and submitting INDs and/or NDAs/BLAs desirable.

ORGANIZATIONAL RELATIONSHIPS

• Reports to relevant GRPL/Sr Dir
• Works with GRA colleagues (esp GRL) and relevant project team(s) members (i.e., Clinical and Project Management, Clinical Operations, Global Regulatory Affairs, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal)
• Partners with regional colleagues, including GRA-in Country colleagues, US Advertising and Promotion, Medical and Commercial colleagues, to provide a regional position
• Works directly or indirectly with external contacts in Regulatory Agencies (i.e. US FDA) within assigned region(s), as well as relevant experts and key opinion leaders
• Ensures alignment with GRL and GRPL

Other Job Details:

• Last Date to Apply for Job: 10 November 2022
• Eligible for Employee Referral Bonus
• NOT Eligible for Relocation Assistance

Work Location Assignment: Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

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