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
- Straightforward 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
- 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.
Key Accountabilities
- Ensure timely delivery of local M1 dossier components
- Act as the initial point of contact 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
- 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)
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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📌 RIO Execution Hub Manager
🏢 Pfizer
📍 City of Sydney