Senior Director Global Regulatory and Operations Lead
2 months ago
Job Summary
EPM 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 data analytics.
Key Responsibilities
- Regulatory Compliance: Ensure continued compliance of EPM Scientific's Regulatory Affairs across multiple countries in the EU and Canada.
- RA Delivery: Oversee RA delivery across multiple countries, utilizing either internal or vendor resources.
- Business Requirements: Deliver RA to meet business requirements within budget.
- RA Budget Management: Track and maintain the RA budget.
- RA Systems Strategy: Develop and implement a clear vision for RA systems, providing strategic direction to senior management for endorsement and approval.
- Technology Evaluation: Evaluate new technologies for future enhancements and improvements, and lead plans for implementation.
- Regulatory Guidance: Evaluate changes in regulatory guidance and highlight impact and strategy management to senior leaders.
- Regulatory Guideline Implementation: Lead corresponding regulatory guideline impact implementation.
- Vendor Oversight: Ensure all systems used within RA are sourced, implemented, maintained, and fit for purpose.
Requirements
- Education: BSc degree in life sciences.
- Regulatory Experience: Extensive work as a regulatory professional essential.
- Leadership Experience: Experience of leading Regulatory Operations (RA experience in EU or Canada).
- Vendor Oversight: Experience of vendor oversight and outsourcing delivery models.
- Leadership Skills: Strong leadership and problem-solving skills.
- Communication Skills: Excellent communication skills and ability to engage with senior leaders within the organization effectively.
- Collaboration Skills: Effective collaborator and strong customer and stakeholder focus.
- Regulatory Knowledge: Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.
-
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 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
5 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...
-
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...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at Gilead Sciences International, Ltd. as a Director, Global Regulatory Affairs, Precision Medicine. This is a unique opportunity to develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with...
