RIO Execution Hub Associate / Sr. Associate

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
• 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

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):

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.S./. 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)

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

ORGANIZATIONAL RELATIONSHIPS

RIO Execution Hub Associate/Sr Associate interacts with

• Country/Cluster teams Submission Manager hubs and other functions across RIO
• GIPE
• RIO Execution Hub Associate/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

RESOURCES MANAGED

• Project specific resources