JOB RESPONSIBILITIES
RIO Execution Hub 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 **
· 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 **
· 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)
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
QUALIFICATIONS / SKILLS
· 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.
Working habits (qualitative examples)
· Colleague who requires management oversight on daily work and support in problem solving.
· Demonstrates technical expertise which aids in task-based execution.
Work Location Assignment: Mexico City, must be able to work from assigned Pfizer office 2-3 days per week, or as needed by the business
**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.
Regulatory Affairs