- POSITION SUMMARY:
Accountable for creating the post approval submissions for Drug Products for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management.
Ensure dossiers (Example: electronic, paper copy, and HA portal) are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
Ensures the processes transparency and excellence in execution of regulatory strategies.
Maintain systems and databases per internal SOPs and policies.
Work in collaboration across the regulatory organization with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in Regulatory submissions and processes.
POSITION RESPONSIBILITIES:
*Manage post approval submissions for a small group of assigned market(s)
*Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
*Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
*Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners
*Capable of authoring some local submission components in relevant databases
*Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
*Liaise with the manufacturing sites for obtaining supporting documents as needed
*Ensure thorough understanding and application of the Hub procedures
*Participate in local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
*Assist in ensuring internal regulatory processes and procedures are well documented.
*Understand local regulations and trends for assigned markets, as communicated by the PCO.
ORGANIZATIONAL RELATIONSHIPS:
*Reports to the Regional Lifecycle Lead or designee.
*Direct Reports: 0 to 2 Lifecycle Strategists
*Key stakeholders: Supply Chain for the markets being supported.
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