Sr. Associate, Regional Regulatory Strategist (RRS) - Global Brands

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 and/or EM).
• Provide regional input and build regulatory expertise for products in the assigned region 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 various development stages, but mostly in early development/registration and/or at post-authorization stage across categories.
  
  

Job Responsibilities

• Supports regional (US, EU and/or EM) above country contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers, intellligence) for assigned project(s) across categories.
• Works across programs with the assigned region/countries to support INDs / CTAs / renewals life cycle activities in the preparation and submission activities, regulatory systems updates and compliance, regulatory correspondence archiving, rapid response team activities, and other duties as assigned.
• 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. BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, 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(s)
  
  

Qualifications / Skills

• Bachelors degree in a scientific field required
• Miminimum 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, supplements and variations to 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 assigned Mgr/Sr. Mgr./ Director/Sr Dir
• Works with GRS colleagues and relevant project team(s) members (i.e. Clinica/Medical Affairs,l and 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
  
  

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!

Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [email protected].

Regulatory Affairs