Rio Execution Hub Associate

Identifying Job Information_

JOB TITLE:
RIO Execution Hub Associate

JOB INFORMATION

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

The RIO Execution Hub Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.
- 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 and
- The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined).

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

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
- Partner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changes.

Local document authoring & submission prep (For reference only)
- 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

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)

Associate
- Colleague who requires management oversight on daily work and support in problem solving.
- Demonstrates technical expertise which aids in task-based execution.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regu