Regulatory Sciences Manager

Deliver Regulatory Strategy and Advise Cross-Functional Teams For assigned product and market responsibilities, develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products. Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process. Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions. Facilitate cross-functional awareness and understanding of regulatory issues and environment, including ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities. Work with above country strategists to provide country input into Global and Regional regulatory strategies as required. Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests. Use expert knowledge of national legislation, guidelines and regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and indirect interactions with external customers. Advise on matters of compliance, national regulatory requirements and Pfizer regulatory policy. Manage New Registration/Marketing Authorisation Applications: National Applications Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EU national Scientific Advice Meetings. Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs. Manage Marketing Authorisation (MA) Variation Applicatio ns Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates). Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders. Work with above-country strategists and above-country operational hubs to supply country documentation/information for dossier build as applicable. Communicate NRA decisions to relevant internal stakeholders as applicable. Manage MA Renewal Applications Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs. Management of NRA queries In partnership with above-country operational hubs and above-country strategists, respond to NRA queries. External Relationships Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations. Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues. Utilise knowledge of NRA’s expectations, ways of working etc to appropriately direct company strategy. Share updates and regulatory intelligence with colleagues. Work with authorities if Pfizer position differs from authority position to obtain a better outcome for the business/patients. Populate and Maintain Regulatory Databases Perform database entry and the document management for regulatory transactions undertaken by Country Regulatory Strategists, in line with global SOPs, if applicable and not performed by above country operational hubs. Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use) Following a request from a prescriber and internal approval to proceed with supply of unlicensed Pfizer medicines to address unmet patient needs, facilitate NRA approval for supply/import via above country operational hubs. Safeguard Compliance in the Management of Packaging and Prescribing Information Component