Sr. Associate, Regional Regulatory Strategist

Job Summary

This position is responsible for developing and implementing European Rest of World (ROW) or US regulatory strategy that aligns with business needs. The purpose of this role is to:

• Work across GRS functions supporting key regulatory tasks and deliverables across programs disease areas and region(s) for regulatory affairs (US EU or EM)
• Provide regional input and build expertise as a member of the Global Regulatory Strategic Team (GRST) level
• Support implementation activities of global/regional regulatory and labeling strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
• Be accountable for timely planning preparation submissions and approvals of program(s) deliverables in the designated region
• Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region.
• Role can be combined with other GRS function activities based upon priorities.
• Project(s) assigned can be in early development/registration and/or at post-authorization stage across categories.

Job Responsibilities

• Supports regional (US EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels risk registers intelligence) for assigned project(s) across categories.
• Works across programs to support INDs / CTAs / renewals 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.
• Partners with project teams and other customer groups (e.g. RU/BU Regional Commercial Teams) to ensure required regulatory contributions (line plans label CTA MAA/IRD variations license renewals etc) meet business needs and are provided to the project teams to agreed time and quality standards.
• Ensures regulatory plans are monitored progress/variance communicated to GRL and Senior Management and any risks (from emerging technical data changing internal objectives or external threats) mitigated
• Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s and that these regulatory positions supporting the regional business are championed and communicated
• Engages in appropriate activities in order to influence the regional regulatory environment through GRS-In Country colleagues Agency contacts and/or Trade Associations as appropriate
• 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 / Skills

• Bachelors degree required
• Minimum of 2 years of experience
• PharmD / PhD / MSc preferred
• 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. Experience preparing and submitting INDs and/or CTAs NDAs / MAA/IRDs desirable. Understanding of key concepts of product label aligned to target product profile and corporate expectations. Prior experience working with regulator(s)
• 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

Organizational Relationships

• Reports to relevant Director/Sr Dir
• Works with GRS colleagues and relevant project team(s) members (i.e. Clinicaland Project Management Development Operations Global Regulatory Affairs Worldwide Risk Management Worldwide Safety Sciences Pharmaceutical Sciences Global Manufacturing Compliance and Legal)
• Partners with regional colleagues including GRS-in Country colleagues Medical and Commercial colleagues to provide a regional position
• Works directly or indirectly with external contacts in Regulatory Agencies 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: 24 JUNE 2025

Work Location Assignment:On Premise

The annual base salary for this position ranges from $77100.00 to $128500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

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

Regulatory Affairs