Current jobs related to Regulatory Manager - Tadworth - Pfizer
-
Senior Regulatory Executive
2 months ago
Tadworth, Surrey, United Kingdom Pfizer Full timeSenior Regulatory ExecutiveContribute to Cross-functional Teams and Build Regulatory Expertise. In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.Represent Regulatory on...
-
Senior Regulatory Executive
2 months ago
Tadworth, United Kingdom Pfizer Full timeSenior Regulatory ExecutiveContribute to Cross-functional Teams and Build Regulatory Expertise. In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.Represent Regulatory on...
-
Regulatory Affairs Specialist
1 day ago
Tadworth, Surrey, United Kingdom Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Sciences team, you will be responsible for representing the EU region in regulatory matters related to our early-stage oncology portfolio.Key ResponsibilitiesDevelop and implement EU regulatory strategies in...
-
Regulatory Affairs Specialist
2 days ago
Tadworth, Surrey, United Kingdom Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Sciences team, you will be responsible for representing the EU region in regulatory matters related to our early-stage oncology portfolio.Key ResponsibilitiesDevelop and implement EU regulatory strategies in...
-
EU Regulatory Strategy Lead
4 weeks ago
Tadworth, Surrey, United Kingdom Pfizer Full timeJob Overview Serve as the principal representative for EU regulatory strategy concerning the specified early phase Oncology portfolio, encompassing regions such as the EU, UK, CH, AUS, and NZ. Guide and participate in the formulation of EU regional strategies for the early phase Oncology portfolio as a vital member of the Global Regulatory Strategic...
-
Head of EU Regulatory Affairs for Oncology
4 weeks ago
Tadworth, Surrey, United Kingdom Pfizer Full timePosition Overview The EU Regulatory Strategy Lead will serve as the primary representative for the European Union (EU) regulatory strategy pertaining to the early phase Oncology portfolio. This role is critical in shaping and overseeing the development of regional strategies while collaborating with the Global Regulatory Strategic Team (GRST). Key...
-
Senior Associate, early phase oncology, Regulatory
2 months ago
Tadworth, United Kingdom Pfizer Full timeJob Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in...
-
EU Lead
2 months ago
Tadworth, United Kingdom Pfizer Full timeJob Summary Primary representative for EU (EU, UK, CH, AUS, NZ) regulatory strategy for the designated early phase Oncology portfolio, Oversee and contribute to the development of EU regional strategies for the designated early phase Oncology portfolio as a member of the Global Regulatory Strategic Team (GRST). Lead, oversee, and/or implement EU...
-
Senior Estates Manager
1 week ago
Tadworth, Surrey, United Kingdom The Children's Trust Full timeAbout the RoleThe Children's Trust is seeking a highly skilled and experienced Senior Estates Manager to join our team. As a key member of our Estates Team, you will be responsible for the operational management of our estate, ensuring compliance with regulatory standards and best practices.Key ResponsibilitiesDevelop and implement effective estate...
-
Senior Estates Manager
1 week ago
Tadworth, Surrey, United Kingdom The Children's Trust Full timeAbout the RoleThe Children's Trust is seeking a highly skilled and experienced Senior Estates Manager to join our team. As a key member of our Estates Team, you will be responsible for the operational management of our estate, ensuring compliance with regulatory standards and best practices.Key ResponsibilitiesDevelop and implement effective estate...
-
Consent and Preference Management Lead, OSS
1 week ago
Tadworth, Surrey, United Kingdom Pfizer Full timeJob DescriptionAbout PfizerPfizer is a global biopharmaceutical company that discovers, develops, and delivers innovative therapies to improve health outcomes for people around the world.Job SummaryThe Omnichannel Services and Solutions (OSS) team at Pfizer is seeking a highly skilled Consent and Preference Management Lead to join our team. As a Consent and...
-
Artwork Implementation Manager
2 months ago
Tadworth, United Kingdom Pfizer Full timeROLE SUMMARY Colleague will fulfil the “Market Coordinator” role in close collaboration with the Global Regulatory Science (GRS) functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the Pfizer Global Supply (PGS) plants/Artwork Centres (AWC). Colleague operates from a Subject Matter Expert (SME) centralised...
-
Senior Manager
2 months ago
Tadworth, Surrey, United Kingdom Fidelity International Limited Full timeAbout the Opportunity Job Type: Permanent Application Deadline: 25 July 2024 Title Senior Manager - Platform Policy Department GPS CIO, MNC/Adviser Product Location Kingswood Reports To Associate Director - Platform Policy & Product Level Grade 6 We're proud to have been helping our clients build better financial futures for over 50 years. How have we...
-
Senior Estates Manager
5 days ago
Tadworth, Surrey, United Kingdom The Children's Trust Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Estates Manager to join our Estates Team at The Children's Trust. As a key member of our team, you will be responsible for managing the operational estate team, ensuring compliance with regulatory standards, and providing exceptional service to our stakeholders.Key ResponsibilitiesManage...
-
Senior Estates Manager
5 days ago
Tadworth, Surrey, United Kingdom The Children's Trust Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Estates Manager to join our Estates Team at The Children's Trust. As a key member of our team, you will be responsible for managing the operational estate team, ensuring compliance with regulatory standards, and providing exceptional service to our stakeholders.Key ResponsibilitiesManage...
-
Marketing Manager
6 days ago
Tadworth, Surrey, United Kingdom Cpl Life Sciences Full timeJob Title: Marketing Manager - Vaccines SpecialistJob Type: ContractLocation: Remote (Hybrid)Job Description:Cpl Life Sciences is seeking a skilled Marketing Manager to join our Vaccines division on a 12-month contract basis. This is an exciting opportunity to work with a global vaccines provider and contribute to the development of their marketing...
-
Marketing Manager
6 days ago
Tadworth, Surrey, United Kingdom Cpl Life Sciences Full timeJob Title: Marketing Manager - Vaccines SpecialistJob Type: ContractLocation: Remote (Hybrid)Job Description:Cpl Life Sciences is seeking a skilled Marketing Manager to join our Vaccines division on a 12-month contract basis. This is an exciting opportunity to work with a global vaccines provider and contribute to the development of their marketing...
-
Quality Assurance Project Manager
1 week ago
Tadworth, Surrey, United Kingdom SRG Full timeJob Overview:SRG is seeking a highly skilled Medical Quality Governance Project Coordinator to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our projects.Key Responsibilities:Project Management: Utilize your exceptional project management skills to coordinate and execute projects...
-
Quality Assurance Project Manager
1 week ago
Tadworth, Surrey, United Kingdom SRG Full timeJob Overview:SRG is seeking a highly skilled Medical Quality Governance Project Coordinator to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our projects.Key Responsibilities:Project Management: Utilize your exceptional project management skills to coordinate and execute projects...
-
Test and DevOps Manager
2 days ago
Tadworth, Surrey, United Kingdom People Source Consulting Full time{"Role": "Senior Test and DevOps Manager", "Location": "Surrey", "Salary": "Competitive", "Job Description": "We are seeking an experienced Senior Test and DevOps Manager to lead the Testing and DevOps operations within our dynamic team. This role ensures the successful delivery of high-quality software and embedded products through efficient testing...
Regulatory Manager
4 months ago
This 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 Management
To 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 Management
Manage 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 Applications
Prepare 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 Applications
Prepare 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 Authorities
In 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.
Devices
Assist regulatory activities for the development and maintenance of medical devices including acting as EU Authorized Representative if required.
Influence Regulatory Authorities
Develop 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 Databases
Accountable 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
