Current jobs related to Senior Director Global Regulatory and Operations Lead - Cambridge, Cambridgeshire - EPM Scientific
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be responsible for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be responsible for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be responsible for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be responsible for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob SummaryEPM Scientific is seeking a highly experienced and skilled Senior Director to lead our Global Regulatory and Operations team. As a key member of our leadership team, you will be responsible for overseeing and strategically directing our Regulatory Affairs operations, including global regulatory, regulatory systems, global vendors, processes, and...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob SummaryEPM Scientific is seeking a highly experienced and skilled Senior Director to lead our Global Regulatory and Operations team. As a key member of our leadership team, you will be responsible for overseeing and strategically directing our Regulatory Affairs operations, including global regulatory, regulatory systems, global vendors, processes, and...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be accountable for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full timeJob Title: Senior Director Global Regulatory and OperationsAs a Senior Director Global Regulatory and Operations, you will be accountable for overseeing and providing strategic direction to Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes, and data analytics.Key Responsibilities:Ensure continued...
-
Global Regulatory Affairs Labeling Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Global Regulatory Affairs Labeling DirectorJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling organization. The successful candidate will be responsible for developing and implementing global labeling strategies, ensuring...
-
Global Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryGilead Sciences International, Ltd. is seeking a highly experienced and skilled Global Regulatory Affairs Director to lead our Regulatory Affairs Labeling function. As a key member of our Innovation, Content, and Operations (ICO) Regulatory Affairs Leadership Team, you will be responsible for developing and implementing global regulatory and...
-
Senior Director Global Regulatory and Operations
2 months ago
Cambridge, UK, Cambridgeshire, United Kingdom EPM Scientific Full timeAccountable for oversight and strategic direction of Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes and data analytics. Accountable for Global RA delivery in certain countries (EU and Canada). Responsible for the strategy and procurement activities for company's Regulatory Affairs...
-
Global Regulatory Affairs Liaison Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob DescriptionJob Title: Director, Global Regulatory Affairs LiaisonJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced and skilled Director, Global Regulatory Affairs Liaison to join our team. As a key member of our Global Regulatory Affairs organization, you will play a critical role in developing and implementing regulatory...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob SummaryGilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.Key...
-
Senior Regulatory Affairs Labeling Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling team at Gilead Sciences International, Ltd. This is a critical role that requires a strong understanding of global labeling regulatory requirements and strategy, as well as excellent leadership and...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob Description:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.Key...
-
Director, Global Regulatory Strategy
6 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob OverviewMoonLake Immunotherapeutics is seeking a highly skilled Director, Global Regulatory Strategy to join our team. This is a critical role that will play a key part in shaping our regulatory strategy and ensuring the successful development and approval of our novel investigational Nanobody.The ideal candidate will have a strong background in...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000Associate Director, Regulatory AffairsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join our team. This is a permanent, full-time opportunity based in Cambridge, UK, with a hybrid/remote work arrangement.About the RoleWe are looking for a highly skilled and motivated individual to lead our regulatory affairs strategy...
-
Global GRC Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom arm limited Full timeJob Title: Global GRC DirectorJob Overview:Arm Limited is seeking a highly experienced Global GRC Director to lead its Governance, Risk, and Compliance (GRC) team. The successful candidate will be responsible for driving best-in-class security, risk programs, and policies to safeguard the company and its partners.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...
-
Global Regulatory Affairs Leader
2 months ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Executive Director, Regulatory Affairs LabelingAbout the Role:Gilead Sciences International, Ltd. is seeking an experienced Executive Director to lead our Regulatory Affairs Labeling function. As a key member of our Global Regulatory Affairs organization, you will be responsible for creating, updating, and maintaining product information and...
Senior Director Global Regulatory and Operations Lead
2 months ago
EPM Scientific is seeking a highly experienced Senior Director to lead our Global Regulatory and Operations team. As a key member of our leadership team, you will be responsible for overseeing the strategic direction and operational delivery of our Regulatory Affairs functions across multiple countries.
Key Responsibilities- Ensure continued compliance of our Regulatory Affairs operations across multiple countries in the EU and Canada.
- Deliver Regulatory Affairs services across multiple countries, utilizing internal or vendor resources as needed.
- Develop and implement strategies to meet business requirements within budget.
- Manage the Regulatory Affairs budget and ensure effective resource allocation.
- Lead the development and implementation of our Regulatory Systems strategy, providing a clear vision to senior management for endorsement and approval.
- Evaluate new technologies for future enhancements and improvements, and lead plans for implementation.
- Monitor changes in regulatory guidance and provide impact assessments and strategies to senior leaders.
- Lead the implementation of regulatory guideline changes and ensure all systems used within Regulatory Affairs are sourced, implemented, maintained, and fit for purpose.
- Bachelor's degree in a life science discipline.
- Extensive experience as a regulatory professional, with a strong background in leading Regulatory Operations teams.
- Experience with vendor oversight and outsourcing delivery models.
- Strong leadership and problem-solving skills, with excellent communication and interpersonal abilities.
- Ability to engage effectively with senior leaders and stakeholders within the organization.
- Effective collaborator with a strong customer and stakeholder focus.
- Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.
