About this role
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 include
General accountabilities (For reference only)
- Ensure timely delivery of local M1 dossier components
- Perform 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 planning.
- Provide support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as requested
- Parther with Grow submission managers and Regional Submission Hubs to meet growth application delivery in line with International Commercial knots prioritisation and OP plans.
- Partner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changes.
Local document authoring & submission prep (For reference only)
- Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations.
- May engage with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities.
- Support 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.
- B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- Advanced to Fluent English language required. Multilingual skills desirable.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Advanced Microsoft Office Suite skills.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
- An understanding of country/cluster regulatory requirements and trends is preferred
- Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred.
Наша цель - Передовые решения, меняющие жизни пациентов
Pfizer – это компания, ориентированная на пациентов, и в своей деятельности мы руководствуемся четырьмя ценностями: смелостью, радостью, справедливостью и совершенством. Культура передовых решений помогает нам в стремлении изменить к лучшему жизни миллионов пациентов.
Сотрудники Pfizer разных стран трудятся вместе, чтобы внести свой вклад в улучшение здоровья людей во всем мире. Мы постоянно работаем над разработкой инновационной терапии и ищем новые возможности для развития, находясь в непрерывных поисках новых талантов.
Гибкая и комфортная рабочая среда
Мы стремимся создавать комфортную и гибкую рабочую среду, которая приветствует соблюдение баланса работы и личной жизни коллег, привлекает таланты и позволяет каждому сотруднику раскрыть свой потенциал. Мы за открытый диалог!
Равная возможность трудоустройства
Мы уверены, что разнообразная и инклюзивная рабочая среда имеет решающее значение для достижения успехов в бизнесе. Как работодатель, Pfizer стремится поддерживать принцип разнообразия, предоставляя сотрудникам возможность быть такими же разными, как пациенты и сообщества, ради которых мы работаем. Вместе мы формируем культуру, которая вдохновляет, поддерживает и развивает наших сотрудников.
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.
Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents.
Flexible Work Environment
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.
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Regulatory Affairs