RIO Execution /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)
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
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial 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)
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.
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
RIO Execution Hub Sr Associate interacts with
Country/Cluster teams, Submission Manager hubs and other functions across RIO
GIPE
RIO Execution Hub Sr Associate can interact with Local affiliate cross functional teams for BAU well defined and simple M1 local components (e.g. Medical, Safety, Clinical, DRSD). informing or via the Country Regulatory team per agreements established
Work Location Assignment: On Premise
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Regulatory Affairs
