Associate Director
3 weeks ago
Associate Director - Global Core Labeling (Regulatory Affairs) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The Associate Director ensures timely delivery of global labeling to our clients affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director leads timely updates and communication of core labeling changes throughout the product lifecyle. Primary Responsibilities: Global Labeling Leadership Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions. Implement Accelerate Reach and Scale initiatives related to global labeling strategy. Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners. Core Labeling Development and Maintenance Lead the development and maintenance of core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL) that includes Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content]. Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC). Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary. Lead the development and maintenance of clinical trial Instructions for Use Labeling Process Excellence Optimize core labeling exception process. Manage core labeling exception requests and facilitate approval from leadership. Support periodic labeling assessments to assess compliance of affiliate product information with core labeling. Serve as subject matter expertfor core labeling. Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes. Anticipate and resolve key technical or operational issues that can impact labeling development and timelines. Develop and present metrics to governance and other forums to monitor and improve the labeling exception process. Lead/Influence/Partner Exemplify the Team behaviors of Include, Innovate, Accelerate, and Deliver. Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers. Participate in forumsthatshareregulatoryinformationacrossGRA components and other teams and business partners. Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy Ensure timely communication of global labeling to global affiliates. Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling. Minimum Qualification Requirements: Bachelors degree in a scientific or health sciences discipline (or equivalent experience). Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years. Demonstrated knowledge of the drug development process and regulatory/business strategies Demonstrated ability to assess and manage risk in a highly regulatory environment. Demonstrated ability to lead, influence and partner cross-functionally. Demonstrated strong communication skills: writing, presenting, listening. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Demonstrated attention to detail and organizational skills. Ability to learn and use new software/technology. Ability to manage multiple tasks simultaneously. For further information please contact: Karen Shiel on or send CV in confidence to Skills: Regulatory Affairs Regulatory Labelling Clinical Trials
-
Audit Associate Director Or Director
3 days ago
Cork, Cork, Ireland Tn Ireland Full timeAudit Associate Director or Director | Asset Management | Cork Client: Clarity Search Partners Location: Cork, Ireland Job Category: Other EU work permit required: Yes Job Reference: f2f Job Views: 72 Posted: Expiry Date: Job Description: Audit Associate Director or Director | Asset Management | Cork Our client is a rapidly growing global practice firm based...
-
Associate Director
5 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy...
-
Associate Director
4 weeks ago
Cork, Cork, Ireland Sonas Technical Full timeAssociate Director Contact Niamh Kedney Salary: Competitive package Location: IrelandLeinsterCork Sector: Construction & Civils Contact: Niamh Kedney Mobile: +353851866731 We are working with a leading consulting and engineering services group on their search for an Associate Director who specialises within the railways/highways ...
-
Associate Director
4 weeks ago
Cork, Cork, Ireland CareerWise Recruitment Full timeJob Description My Client, a reputable Multinational in Cork, is looking to recruit an Associate Director for the Financial planning team. This position reports directly to the Associate Vice President in Finance and is a key member of the Finance Leadership team. The role offers a very competitive salary, a hybrid working option, benefits and...
-
Associate Director
4 weeks ago
Cork, Cork, Ireland Snc-Lavalin Full timeAssociate Director (Bridges) - CorkAssociate Director (Bridges) - CorkAtkinsRéalis is one of the world's leading providers of engineering professional consulting and support services with offices across Ireland.AtkinsRéalis Ireland is seeking a dynamic and experienced Associate Director to join our thriving Bridge Design Team in Cork. With a substantial...
-
Associate Director
2 weeks ago
Cork, Cork, Ireland Snc-Lavalin Full timeAssociate Director (Bridges) - CorkAssociate Director (Bridges) - CorkAtkinsRéalis is one of the world's leading providers of engineering professional consulting and support services with offices across Ireland.AtkinsRéalis Ireland is seeking a dynamic and experienced Associate Director to join our thriving Bridge Design Team in Cork. With a substantial...
-
Audit Associate Director or Director
4 weeks ago
Cork, Cork, Ireland Clarity Search Partners Full timeAudit Associate Director or Director | Asset Management | Cork Our client is a rapidly growing global practice firm based in Cork City. They require an experienced Audit Director to join their team. Experienced Audit Senior Managers will also be considered. This is a great opportunity to join a dynamic firm with ambitious plans for further expansion. ...
-
Audit Associate Director or Director
2 weeks ago
Cork, Cork, Ireland Clarity Search Partners Full timeAudit Associate Director or Director | Asset Management | CorkOur client is a rapidly growing global practice firm based in Cork City. They require an experienced Audit Director to join their team. Experienced Audit Senior Managers will also be considered.This is a great opportunity to join a dynamic firm with ambitious plans for further expansion.Main...
-
Associate Director of Regulatory Operations
6 days ago
Cork, Cork, Ireland Life Science Recruitment Full timeLIFE SCIENCE RECRUITMENT seeks a seasoned Associate Director of Regulatory Operations. As an Associate Director - Global Core Labeling, you will lead the development and maintenance of global labeling for our clients.Your key responsibilities will include providing leadership for the development of global labeling strategy, implementing 'Accelerate Reach and...
-
Associate Director
3 weeks ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director - Clinical Regulatory Scientist Our client, a global pharma company are currently recruiting for an Associate Director - Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team and a permanent basis. As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US...
-
Associate Director
7 days ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director - Clinical Regulatory Scientist Our client, a global pharma company are currently recruiting for an Associate Director - Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team and a permanent basis.As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US and...
-
Associate Director
6 hours ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Laboratory Development Associate Director
6 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeJob DescriptionThe Therapeutic Area (TA) Associate Director/Director, Clinical Laboratory Sciences will have early engagement with business and therapeutic partners on clinical laboratory development. This role requires in-depth knowledge and expertise in clinical laboratory practices and processes.This position involves project management at a molecule...
-
Associate Director
2 weeks ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate Director
7 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate Director
2 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate Director Life Sciences
4 days ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeLIFE SCIENCE RECRUITMENT LTD is seeking an exceptional clinical professional to join their team as Associate Director Life Sciences. As an Associate Director Clinical Development, you will partner with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans....
-
Associate Director of Regulatory Excellence
7 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeJob DescriptionThe Associate Director of Regional Regulatory Scientist provides strategic leadership and technical expertise to ensure regulatory compliance and excellence across the organization. This role requires collaboration with cross-functional teams, including molecule development, quality assurance, and compliance.Key responsibilities include...
-
Associate Director
6 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate Director of Diagnostic Development
5 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAbout Eli Lilly And CompanyWe are a global healthcare leader committed to improving human health through innovation and dedication. Our team at Eli Lilly Cork is driven by a passion for making a difference in people's lives.As a global healthcare leader, we are headquartered in Indianapolis, Indiana, with employees worldwide working tirelessly to discover...
