RIO Execution Hub Sr. Associate
About this opportunity
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)
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
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 83 comparable Senior Regulatory Affairs roles across 41 biopharma companies.
Salary context
32 of 83 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 83 comparable roles
+ 15 more countries
Seniority mix
83 of 83 peers have a known seniority level
Therapeutic area mix
9 of 83 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.