Regulatory Manager

JOB SUMMARYThis is an individual contributor / career development role, with room to grow into managing direct reports. The role entails strategy, working on own initiative and taking on projects, as detailed below.There will be opportunities to lead, motivate, inspire and develop direct reports; management of projects and strategy at a departmental level; management of permanent staff and contractors; contributing to the strategic regulatory input into cross-functional product teams for licensed and development products and the implementation of special projects for country markets; overseeing the management of Clinical Trial Authorizations (where applicable), new Marketing Authorizations and maintenance activities; monitor team performance to ensure colleagues fully comply with Company and statutory tasks and compliance obligations and provision of regulatory advice to, and liaison with, key customers and relevant stakeholders.Allow Pfizer to legally study, manufacture, market and supply medicines. To obtain, manage and maintain product Marketing Authorizations and Clinical Trial Authorizations in line with business goals and legal requirements. Conduct associated regulatory activities for the specified markets, and to contribute to the implementation and leading of projects and building of expertise within the Regulatory Department.Work Location Assignment: Flexible (Walton Oaks, Surrey or Watermarque, Dublin)RESPONSIBILITIES :Department & Project ManagementTo be accountable for identifying, implementing and managing key Regulatory Departmental projects either on an individual basis or as part of the Regulatory Management Team, based on both short and long term Regulatory Department objectives including agreement of relative project priorities with Head of Regulatory Sciences as appropriate.To play a lead role in ensuring that the Regulatory Department has effective and efficient processes in place.To participate in/lead, cross-functional project teams, to address business needs in line with Global/Regional GRS and UK/Irish business objectives and strategic imperatives.To monitor regulatory activities across product therapy areas in accordance with reporting lines and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements and timelines.Deputize for Head of Regulatory Sciences as required. People and Resource ManagementManage performance of direct reports to achieve established objectives, with high quality outputs, and to identify and address training and development needs.Ensure regulatory team members work effectively in a productive and well motivated environment through providing ongoing coaching, guidance and relaying of regulatory expertise.Ensure direct reports are assisted and that direct reports have a manageable workload through redistribution, prioritization or outsourcing of work, as necessary including planning of appropriate timelines and resource allocation. Include consideration of individual strengths when allocated project/product tasks.Participate in the recruitment of new staff as required.Ensure systems are in place and adhered to, to optimize process efficiency.Contribute to Cross-functional Teams and Build Regulatory Expertise.In line with defined product responsibilities, utilize regulatory expertise to develop and deliver optimal regulatory strategies and plans to assist the achievement of country business goals for both licensed and development product.Represent Regulatory on product based teams.Provide regulatory input to commercial strategic and operating planning process.Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and assistance for teams as necessary. Ensure teams comprehend the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.Build personal expertise through management of specified products within one or more therapy areas.Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.Work with GRS regional strategists to provide country specific input into Global and European Regulatory Strategies as required.Seek to improve alignment of local and regional regulatory strategy and tactics.Provide Regulatory Advice and Information to meet Customer and cross-divisional colleague requests.Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful replies to enquiries from Pfizer cross-divisional colleagues and direct or indirect interactions with external customers.Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy.Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.Manage and Submit Marketing Authorization Applications:National/MRP/Decentralised MAA: Partner with above-country operational hubs and above-country strategists to review, co-ordinate and, where required, create necessary technical data to assist country submissions e.g. provide national specific module 1 data review & approve proposed regulated documents (SPC, PIL & Labelling) & associated artwork in line with regulations.Centralised MAA: Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.Manage and Submit MA Variation ApplicationsPrepare Module 1 documents in partnership with above-country operational hubs. Review data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.Prepare Module 2 documents in partnership with above-country operational hubs, above-country strategists and local medical functions.Work with above-country strategists and, above-country operational hubs to supply country documentation to support Centralised product variations and to ensure effective coordination of Mutual Recognition and Decentralised variations.Lead MRP/DCP submission review and planning where country is RMS, in conjunction with above-country strategist.Manage and Submit MA Renewal ApplicationsPrepare Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements.Management of Safety Reports and Issues with Regulatory AuthoritiesIn partnership with above-country operational hubs and above-country strategists, reply to Regulatory Authority queries and input to aggregate safety reports.Provide calendar data to above-country operational hubs, as needed.DevicesAssist regulatory activities for the development and maintenance of medical devices including acting as EU Authorized Representative if required.Influence Regulatory AuthoritiesDevelop and 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 local knowledge of Regulatory Authority's expectations, ways of working etc to appropriately direct company strategy. Relay updates with colleagues.Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.Reply to spontaneous requests from authorities promptly and accurately.Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.Manage Clinical Trial Approvals (if performed in country)Liaise with clinical research project managers to seek to understand clinical research programme.In partnership with above-country operational hubs, above-country strategists, and local clinical operations or third party vendors, prepare established CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including reply to Regulatory Authority queries.Ensure timely communication of any GCP breaches, or actions taken for safety reasons. Populate and Maintain Regulatory DatabasesAccountable for database entry and the document management of regulatory transactions undertaken at local level.Accountable for database entry and archival of regulatory material required at local level.Participate in ad hoc and routine QC checking of regulatory data bases.Safeguard Compliance and Manage Packaging and Prescribing Information Component updates In partnership with above-country operational hubs, above-country strategists, and local stakeholders (e.g. Demand Management, logistics, medical, commercial, quality), manage packaging, artwork and labelling components to ensure their introduction within regulatory compliance timelines. Via defined procedures notify relevant internal customers of changes to packaging components and prescribing information and the timelines for associated implementation activities. . click apply for full job details
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