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Regulatory Affairs Hub Management Specialist
2 weeks ago
The Regulatory Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams. This role acts as the 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.
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 include:
1. Ensure timely delivery of local M1 dossier components
2. 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.
3. 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.
4. 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).
The ideal candidate will have a strong background in Regulatory Affairs with experience in managing international dossiers and maintaining compliance with regulatory requirements. He/she must possess excellent communication and project management skills, with the ability to work effectively in a team environment.
Additionally, the candidate should have knowledge of pharmaceutical organizational structures, systems, and culture, as well as an understanding of country/cluster regulatory requirements and trends.
Relevant experience within pharma, in Regulatory, quality and/or compliance fields, is highly desirable.
Benefits:The successful candidate will have the opportunity to work in a dynamic and fast-paced environment, with exposure to cutting-edge technology and innovative solutions.
They will also have access to ongoing training and development opportunities, to enhance their skills and knowledge in Regulatory Affairs.
Others:Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
