JOB SUMMARY

The RIO Execution Hub Associate/Sr Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.

The Execution Hub Associates/Sr Associates work across portfolio phases from initial registration applications, lifecycle management through to product withdrawal. They support numerous regulatory activities that include but are not limited to:

M1 dossier components (local document authoring and/or coordination)Simple local only HA query responsesProvide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning

It is expected that this role partners closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to:

Identification of regulatory requirements (for the in-scope submission categories defined),Authoring, delivery and/or coordination of local, submission-ready documentsThe quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined)

JOB RESPONSIBILITIES

RIO Execution Hub Associate/ /Sr Associate is focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country/therapeutic area/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. Associated functions are engaged to provide smooth operational performance and process efficiency.

This role executes the GRS mission by delivering against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory International and operational support. A key component of this role is the implementation of portfolio execution efficiencies, identification and escalation of quality and compliance issues or emerging risks detected during the management of the Cluster/Country submissions under his/her responsibility. 

Success in this role is measured by the timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization.

In some regions/clusters, the RIO Execution Hub can execute the role of Hub Submission Manager, while in others should closely partner with Hub Submission Manager.

KEY ACCOUNTABILITIES

General accountabilities (For reference only):

Ensure timely delivery of local M1 dossier componentsPerform Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submissions under his/her responsibility)Can provide support for simple tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and regulatory information status for launch planningProvide support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as requestedParther with Grow submission managers and Regional Submission Hubs to meet growth application delivery in line with International Commercial knots prioritisation and OP plansPartner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changesLocal document authoring & submission prep (For reference only)Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translationsMay engage with Labeling Hubs and  clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activitiesSupport clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy

Portfolio – Non Portfolio Support (qualitative examples):

Associate

Business Experiences:

Provides regulatory support to lower complexity regulatory activities in the assigned country/Cluster (mainly  for commercial lifecycle through to product withdrawal) and applies technical experience to impact business results

Non-Portfolio Experiences:

Provides input to projects requested within RIO Hubs

Senior Associate

Business Experiences:

Provides regulatory support to lower to medium complexity regulatory activities in the assigned country (Initial applications, commercial lifecycle through to product withdrawal, simple tenders, audits, launch planning support) and applies technical experience to impact business results

Non-Portfolio Experiences:

Provides subject matter expert (SME) input to projects that impact people, technology, and/or processes within RIO Hubs, GI&PE and GRS

QUALIFICATIONS / SKILLS

B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be consideredAdvanced to Fluent English language required. Multilingual skills desirableProven technical aptitude and ability to quickly learn and use new software, regulations and quality standardsAdvanced Microsoft Office Suite skillsFamiliarity with pharmaceutical organizational structures, systems, and culture is preferred.An understanding of country/cluster regulatory requirements and trends is preferredRelevant experience within pharma, in Regulatory, quality and/or compliance fields preferred

Working habits (qualitative examples)

Associate

Colleague who requires management oversight on daily work and support in problem solvingDemonstrates technical expertise which aids in task-based execution

Senior Associate

Self-initiates problem solving and is able to navigate ambiguous situations impacting RIO through to results. Recognizes when escalation is requiredDemonstrates technical expertise which aids submission execution

ORGANIZATIONAL RELATIONSHIPS

RIO Execution Hub Associate/Sr Associate interacts with

Country/Cluster teams, Submission Manager hubs and other functions across RIOGIPERIO Execution Hub Associate/Sr Associate can interact with Local affiliate cross functional teams for BAU well defined and simple M1 local components (e.g. Medical, Safety, Clinical, DRSD). informing or via the Country Regulatory team per agreements established

RESOURCES MANAGED

Project specific resources

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 sygnalisci-px@pfizer.com.

Regulatory Affairs