Regulatory Manager in South Cave

The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs. Contribute to the implementation and leadership of projects and building expertise within the cluster regulatory team.

JOB RESPONSIBILITIES

• 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 Authorization 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.
• For EU MRP/Decentralised MAAs: Partner with above-country operational hubs and above-country strategists to review and where required, provide country specific module 1 data. Facilitate local launch date planning and NRA approval of additional risk minimization measures, as applicable.
• Manage Marketing Authorization (MA) Variation Applications: 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.
• Support EU Regulatory Strategist with submission strategy negotiation with Reference Member State (RMS) Regulatory authorities and manage contact with Concerned Member State (CMS) Regulatory authorities.
• 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. Utilize knowledge of NRAs 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.
• Clinical Trials: Support the following strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable: Optimization of Clinical Development Plan (CDP) and Country Footprint. Communications with NRAs to clarify questions during assessment as required by CTRSE. Support Regulatory Requirements Manager (RRM) updates for local Clinical Trial Applications (CTAs) and study conduct requirements. Participation in national CTA Trade Association working groups and advocacy activities.
• Additionally for EU countries only: Selection of Reporting Member State (RMS). Support contact with RMS and Concerned Member State (CMS) national Regulatory Authorities as required for any scientific interaction at a program (Scientific Advice) or study level (Pre-CTA/Pre-vetting meetings).
• 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: 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 updates: Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities. Negotiate extensions to packaging artwork implementation with Regulatory Authorities when applicable.
• Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity: Working with local stakeholders and above country operational Hubs, where applicable: Divestments: Advise business on regulatory activities required prior to divestment/transfer of license. Support license transfer. Discontinuations: Liaise with local Commercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace. Upon receipt of above-country endorsement to proceed, trigger applicable notification to NRA and other external stakeholders as required by national regulations. Cancellations: Upon receipt of in and above-country endorsement to proceed, manage applicable notification/request to NRA, as required by national regulations. Notify relevant colleagues of approval of the license cancellation. Interruptions to Supply: Notify Regulatory Authorities of interruptions to supply in accord with national regulations and as agreed with cross functional team. Work with cross functional team to explore options to help minimize or mitigate the out of stock. Obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable.
• Support Third Party Licenses: Manage relevant, local regulatory activities related to supporting third party licenses for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs.
• Devices: Support regulatory activities for the development and maintenance of medical devices if required.
• Contribute to Good Regulatory Practice (GRP): Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained. Help identify changes to business processes to improve them as necessary, including to reflect changes in regulations. Through maintenance of regulatory activities in line with company procedures for own products, contribute to inspection ready state.
• Support Regulatory Group Development: Contribute to and support as necessary, the maintenance and development of the cluster/country Regulatory team through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures. Support drive towards Pfizer and GRS Vision and Values.
• Lead Personal Development: Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximize/optimize career development and contribution to the business. Develop product and therapeutic area knowledge as needed, according to product responsibilities list. With support of line management build on competency strengths and address any development areas. Act as a senior mentor/coach for less experienced colleagues.

Work Location Assignment: Hybrid (some office presence is required)

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