Execution Hub Associate/Sr. Associate
- Korea, Republic of - Seoul
(Fixed Term: 12-24 mos)
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 responses,
Provide 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 documents and
The 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 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
Partner with Growth 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.
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.Sc. in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
Advanced to Fluent Korean and 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.
Associate
Colleague who requires management oversight on daily work and support in problem solving.
Demonstrates 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 required.
Demonstrates technical expertise which aids submission execution.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)