Director Regulatory Process
1 miesiąc temu
Act as Regulatory Process Lead, to lead their nominated area within Regulatory Processes. Regulatory Nominated Areas Include: Clinical Trials, License Maintenance, Marketing Application and Regulatory
Information a Management. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology and services within the area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.Accountable to develop relationships across Regulatory Affairs organisations and other relevant areas of AZ to execute the delivery of the process's strategy, priorities, alongside governance and management of the current procedural documents
Typical Accountabilities :
Accountable for the oversight, lifecycle management and strategic planning and development of nominated area and the Regulatory owned processes and procedural documents of their nominated area and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies. Owns and is accountable for the long term stewardship of their nominated area and for successful delivery of the business benefits. Fulfill all required responsibilities of BPO role as described in R&D Process Governance framework, when tasks delegated to Associate Directors/Manager/SMEs accountability for setting and communicating strategy and timelines remain. Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement. Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the Regulatory area they lead. Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements and provide feedback and clear rationale for any areas that will not be addressed. Ensures that internal processes are fit for purpose, working with relevant stakeholders to improve processes. Partner with Systems team counterparts to ensure an integrated and holistic approach to processes and systems. Act as the primary point of escalation for personnel for any risks and issues identified within the assigned area. Work with the Head of Reg Process and Compliance and other stakeholders to monitor the overall performance of the processes and technology within the nominated area. TMonitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through theQuality & Risk Management process Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industryintelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams. Where applicable, in partnership with peers (Other Nominated Area Leads) establish, foster and facilitate a top tier partnership relationship with the outsource provider. Ensures that all internal and external relationships and interfaces are managed effectively.Essential :
University degree or equivalent qualification in relevant scientific discipline Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role. Experience from authoring standards documents (Standard Operating procedures) Experience from development and provision of training through virtual meetings and other media Experience of leadership of team, either as line manager or project leader Experience in outsourcing and partnership with external vendors and to manage multiple stakeholders Extensive knowledge in project management skills, specifically leading teams Demonstrated excellent skills in: written and verbal communication Able to work with high degree of autonomy Able to represent AstraZeneca externally where requiredDesirable :
PhD in scientific discipline · Knowledge of new and developing regulatory and pharmacovigilance expectationsKey capabilities:
Understanding of governance processes Process improvement (eg Lean methodology) Collaboration/co-ordination Financial awareness Ability to influence without authority Open to multiple perspectives Balanced perspective Solution focused Experience with inspection activitiesDate Posted
15-May-2024Closing Date
03-Jun-2024Mamy inne aktualne oferty pracy związane z tym obszarem, które można znaleźć poniżej
-
Associate Director, Regulatory Process
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatWorking with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Specifically for this role the focus is intended to be CMC variation process and CMC contribution to overall Regulatory Business Processes. ...
-
Associate Director, Regulatory Process
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatWorking with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Specifically for this role the focus is intended to be CMC variation process and CMC contribution to overall Regulatory Business Processes. ...
-
Director, Bioethics
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatDirector, Bioethics Location: Warsaw, hybrid work: 3 days from the office, 2 days from home The Chief Medical Office (CMO) Bioethics delivers R&D standards that guide the ethical development and delivery of medicines to patients. The job holder reports to Senior Director, Bioethics and acts as a functional Leader in relation to optimizing,...
-
Director, Statistical Programming
2 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatDirector, Statistical Programming Hybrid work, Warsaw Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at...
-
Pharmacovigilance Scientists
1 miesiąc temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatPharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...
-
Pharmacovigilance Scientists
4 tygodni temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatPharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...
-
Pharmacovigilance Scientists
3 tygodni temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Associate Director, Statistical Programming
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...
-
Associate Director, Statistical Programming
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...
-
Associate Director Business Process Owner
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatJoin our Business Process Management and Optimization team in the Biopharmaceuticals Clinical Operations organisation. You will work collaboratively with Functional Process and/or Subject Matter Experts across all relevant departments, ensuring that processes are developed and handled effectively and efficiently. This role is a unique opportunity to...
-
Medical Affairs Director
4 tygodni temu
Warsaw, Polska Novo Nordisk AS Pełny etatAre you a strategic thinker with a passion for driving scientific communication and building relationships within the medical community? Are you ready to lead and execute on the medical activities and projects? If so, we have an exciting opportunity for you to join our team as a Medical Affairs Director at Novo Nordisk. Read on and apply today for a...
-
Medical Affairs Director
4 tygodni temu
Warsaw, Polska Novo Nordisk Pełny etatAre you a strategic thinker with a passion for driving scientific communication and building relationships within the medical community? Are you ready to lead and execute on the medical activities and projects? If so, we have an exciting opportunity for you to join our team as a Medical Affairs Director at Novo Nordisk. Read on and apply today for a...
-
Director of Financial Reporting CEE
3 dni temu
Warsaw, Polska Michael Page Pełny etatDirector of Financial Reporting CEE Miejsce pracy: Warszawa Recruitment for Our client is a global consulting firm specializing in strategic advisory services. They provide tailored solutions in areas such as business strategy, M&A, market research, operational optimization and digital transformation. We are currently recruiting for the position of Director...
-
Regulatory Affairs Manager
3 tygodni temu
Warsaw, Polska Innovaderm Research Pełny etatThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...
-
Regulatory Submission Specialist
2 miesięcy temu
Warsaw, Polska Publicis Le Pont Pełny etatJob Description As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and project management. The role will be perfect for you if you have strong...
-
Regulatory Submission Specialist
4 tygodni temu
Warsaw, Polska Publicis Le Pont Pełny etatJob Description As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and project management. The role will be perfect for you if you have strong...
-
Finance Director
4 tygodni temu
Warsaw, Polska JLL Pełny etatJLL WPM CLIENT FINANCE JOB DESCRIPTION Job TITLE : Foreign, Commonwealth & Development Office for Europe - Finance Director Business Unit : Workplace Management EMEA Work location : Poland Type : Permanent Role summary The FCDO European Finance Director is a senior leadership role, managing for the Client Property Operating expenses...
-
Warsaw, Polska AstraZeneca Pełny etatStatistical Programming Associate Director, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead clinical studies,...
-
Senior Regulatory Specialist, Country Labelling
4 tygodni temu
Warsaw, Polska 9605 GSK Services Sp z o.o. Pełny etatThe Senior Regulatory Specialist, Country Labelling is responsible for effective coordination, communication and maintenance of regional/country labelling documents (for multiple markets/regions) and data in regulatory systems in accordance with defined standards and processes. You will provide support to GRA Labelling colleagues, Regulatory Matrix Teams...
-
Warsaw, Polska IQVIA Pełny etatPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
