RIO Execution Hub Manager

Pfizer Sydney, New South Wales, Australia

Join or sign in to find your next job

Join to apply for the RIO Execution Hub Manager role at Pfizer

Pfizer Sydney, New South Wales, Australia

1 week ago Be among the first 25 applicants

Join to apply for the RIO Execution Hub Manager role at Pfizer

Get AI-powered advice on this job and more exclusive features.

Job Summary

The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.

Job Summary

The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.

The Hub Managers work across portfolio phases from initial applications, commercial lifecycle 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 support 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.
  
  

This role acts as initial point of contact for assigned Country/Cluster under his/her responsibility for Country Regulatory Strategist, Hub Submission manager/Dossier Manager, and other key stakeholders involved in the processes described above.

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

RIO Execution Hub manager 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 portfolio 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 manager 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
• Act as the initial point of contact for for assigned cluster/country under his/her responsibility for RIO Execution Hub Team Lead and key stakeholders, including the Country Regulatory Strategist and Hub Submission manager, for the processes under his/her responsibility.
• Provide Regulatory support for x-functional support assigned to him/her to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
• Provide support for local audit readiness activities including audit interviews as needed, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as required.
• Support country regulatory strategists with country x-functional meetings e.g., on launch plans, as required.
• 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).
• Partner with Grow submission managers and Regional Submission Hubs to deliver
• Growth applications to meet International Commercial knots prioritisation and Op plans.
• Support RIO and International Regional Leadership partnering with Submission Hubs for
• International Commercial knot prioritisation discussions for Op plan cycle.
• GRS lifecycle prioritisation discussions 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.
  
  

Manager

Business Experiences:

• Provides regulatory support to simple and complex regulatory activities in the assigned country/cluster (e.g., Initial applications, commercial lifecycle through to product withdrawal, tenders, audits, launch planning) and applies technical experience to impact business results.
• Lead regulatory support to countries/clusters with challenging internal and external constraints.
• Acts as a regulatory matter expert with extensive regulatory expertise working across different clusters and/or regions to consolidate Regulatory activity, with close matrix collaboration with strategists and other local and above country cross-functional stakeholders.
  
  

Non-Portfolio Experiences:

• Represents the RIO function and plays key roles in RIO, GI&PE and GRS improvement projects
  
  

Non-Portfolio Experiences:

• Leads continuous improvement projects that impact people, technology, and/or processes within RIO Hubs, and/or represent RIO playing key leadership roles in transformation projects in broader GI&PE and GRS.
  
  

Requirements:

• 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.
• An understanding of country/cluster regulatory requirements and trends is preferred.
• Relevant experience within pharma, in Regulatory, quality and/or compliance fields.
  
  

Working habits (qualitative examples)

• A colleague who does not require management oversight on daily work, self-initiates problem solving and is able to navigate ambiguous situations impacting GRS and beyond through to results. Recognizes when escalation/status updates are required.
• Demonstrates domain expertise which drives execution in complex submission strategies and impacts outcomes on business results.
• Demonstrated experience in matrix management where the colleague does not have autonomy.
• Pre-empts internal / external risk to organization and raises/ partners to mitigate.
  
  

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory AffairsSeniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionManagement and Manufacturing
• IndustriesPharmaceutical Manufacturing

Referrals increase your chances of interviewing at Pfizer by 2x

Get notified about new Hub Manager jobs in Sydney, New South Wales, Australia.

Sydney, New South Wales, Australia 3 days ago

Strategy and Operations Senior Manager, APAC

Sydney, New South Wales, Australia 1 day ago

Senior Manager, People & Culture Operations

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 3 months ago

Operations Manager - Titling and Plan ServicesCustomer Operations Manager, HomeIn, x15ventures

Sydney, New South Wales, Australia 2 days ago

Information Technology Operations Manager

Sydney, New South Wales, Australia 5 days ago

Sydney, New South Wales, Australia A$145,000.00-A$145,000.00 3 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Operations Manager - Community Health Services

Randwick, New South Wales, Australia 4 days ago

Sydney, New South Wales, Australia 2 days ago

Clinical Operations Manager – Allied Health, NDIS & Health Tech

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 3 weeks ago

Surry Hills, New South Wales, Australia 1 day ago

Service Operations Manager - AI Accelerator

Sydney, New South Wales, Australia 4 hours ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Store Operations Manager - Permanent Full-time or Part-time

Sydney, New South Wales, Australia 2 weeks ago

Surry Hills, New South Wales, Australia 2 weeks ago

Strategy and Operations Manager, Rider Operations

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 1 day ago

Sydney, New South Wales, Australia 1 day ago

Sales Operations Manager @ Leading fintech company

Sydney, New South Wales, Australia 1 day ago

Senior Manager, Operations and Governance

Sydney, New South Wales, Australia 6 days ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 1 month ago

Strategy & Operations Manager, Restaurant Selection

Sydney, New South Wales, Australia 5 days ago

Sydney, New South Wales, Australia 6 days ago

Sydney, New South Wales, Australia 2 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

---