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The Role
Manages multi-regional, regional, and national pharmaceutical regulatory dossiers from initial registration through lifecycle management and withdrawal. Prepares and reviews local dossier documents, coordinates submissions and labeling updates, supports regulatory queries, audits, launch planning, and compliance activities, and identifies quality risks and process efficiencies. Partners with submission hubs, country teams, and subject matter experts to deliver timely, compliant regulatory outcomes.
Summary Generated by Built In
RIO Execution Hub 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.
Key Accountabilities include:
General accountabilities (For reference only)
Local document authoring & submission prep (For reference only)
Portfolio - Non Portfolio Support (qualitative examples)
Senior Associate
Business Experiences:
Non-Portfolio Experiences:
Qualifications:
Working habits (qualitative examples)
Senior Associate
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
#BI-Hybrid
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.
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)
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:
- 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.
Working habits (qualitative examples)
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.
- 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.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
#BI-Hybrid
Skills Required
- Bachelor’s degree in Pharmacy, Life Sciences, Business, or Information Technology, or equivalent relevant professional experience
- Advanced to fluent English language skills
- Technical aptitude and ability to quickly learn new software, regulations, and quality standards
- Advanced Microsoft Office Suite skills
- Familiarity with pharmaceutical organizational structures, systems, and culture
- Understanding of country or cluster regulatory requirements and trends
- Relevant pharmaceutical experience in regulatory, quality, or compliance fields
- Multilingual skills
What the Team is Saying
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Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, and robust mental‑health benefits, with eligible Pfizer medications available at no cost in U.S. plans. Family‑building support and transgender‑inclusive care are explicitly included, alongside wellbeing resources such as a reimbursement wallet and telehealth options.
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Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional Retirement Savings Contribution, complemented by company‑subsidized life, short‑term disability, and long‑term disability insurance. Materials also reference subsidized retiree medical coverage for eligible groups.
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Leave & Time Off Breadth — Paid vacation, holidays, personal days, and paid parental and caregiver leave are consistently highlighted in current U.S. summaries and job postings. Options like buying extra vacation days and transition‑back support strengthen the time‑off offering.
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The Company
What We Do
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.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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