Global Regulatory Affairs Leader
7 hours ago
The role is responsible for leading the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.
Key Responsibilities:- Develop a global labeling strategy that facilitates simultaneous submissions worldwide.
- Implement initiatives to accelerate regulatory processes and improve labeling efficiency.
- Represent the company in global regulatory matters and collaborate with cross-functional teams.
- Lead the creation and maintenance of core labeling content, including Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content.
- Communicate initial and revised core labeling to global affiliates and provide consultation as needed.
- Optimize the core labeling exception process and manage exception requests.
- Develop and present metrics to stakeholders to monitor and improve the labeling exception process.
- Bachelor's degree in a scientific or health sciences discipline or equivalent experience.
- A minimum of 2 years of industry-related experience in regulatory affairs and/or drug development.
- Demonstrated knowledge of the drug development process and regulatory/business strategies.
- Ability to assess and manage risk in a highly regulated environment.
- Leadership and collaboration skills to drive cross-functional partnerships.
-
Regulatory Affairs Manager
1 week ago
Cork, Cork, Ireland Cpl Full timeRegulatory Affairs Manager – PharmaLocation: Cashel | Permanent | Full-TimeAbout The RoleWe are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.What You'll DoLead regulatory strategy for...
-
Regulatory Affairs Manager
6 days ago
Cork, Cork, Ireland Cpl Full timeRegulatory Affairs Manager – PharmaLocation: CashelEmployment type: Permanent | Full-TimeAbout The RoleWe are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.What You'll DoLead regulatory...
-
Global Regulatory Affairs Specialist
2 weeks ago
Cork, Cork, Ireland beBeeRegulatory Full time €96,000 - €124,000Job OverviewWe are seeking a highly skilled Regulatory Affairs professional to join our team. The successful candidate will be responsible for leading the development and implementation of global regulatory strategies, ensuring compliance with all relevant regulations and guidelines.The ideal candidate will have a strong background in regulatory affairs,...
-
Global Regulatory Affairs Director
1 day ago
Cork, Cork, Ireland beBeeDirector Full time €100,000 - €120,000Job Title: Global Regulatory Affairs DirectorThis position plays a crucial role in leading the global labeling strategy for pharmaceuticals, ensuring timely delivery of core labeling documents and collaboration with cross-functional teams.Key Responsibilities:Develop and implement a comprehensive global labeling strategy to facilitate simultaneous global...
-
Regulatory Affairs Specialist
2 weeks ago
Cork, Cork, Ireland Danaher Life Sciences Full timeRegulatory Affairs Specialist - 12 month FTC -Maternity CoverJoin to apply for the Regulatory Affairs Specialist - 12 month FTC -Maternity Cover role at Danaher Life SciencesRegulatory Affairs Specialist - 12 month FTC -Maternity Cover1 day ago Be among the first 25 applicantsJoin to apply for the Regulatory Affairs Specialist - 12 month FTC -Maternity Cover...
-
Regulatory Affairs Professional
5 days ago
Cork, Cork, Ireland beBeeRegulatory Full time €65,500 - €98,100Regulatory Affairs SpecialistThis is a contract position that offers full benefits. We are seeking a Regulatory Affairs Specialist to join our team.Job Description:Evaluate regulatory data to support the development of local, regional, and global regulatory strategies.Participate in advocacy activities of a technical and/or tactical nature.Analyze the...
-
Regulatory Affairs Specialist
2 weeks ago
Cork, Cork, Ireland Danaher Life Sciences Full timeOverviewWondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates...
-
Regulatory Affairs Professional
4 days ago
Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €90,000Regulatory Affairs SpecialistThe role of Regulatory Affairs Specialist plays a vital part in ensuring compliance with regulatory requirements.Main Responsibilities:Evaluating the regulatory environment and providing advice throughout the product lifecycle to ensure product compliance.Assessing regulatory intelligence to develop global regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Cork, Cork, Ireland beBeeSpecialist Full time €70,000 - €104,000Regulatory Affairs Specialist JobWe are seeking a skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Assess regulatory intelligence to inform the development of local, regional, and global regulatory strategies.Participate in advocacy activities of a technical and/or tactical nature.Evaluate the regulatory environment and provide...
-
Regulatory Affairs Specialist
1 day ago
Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000Regulatory Affairs SpecialistA Career in Regulatory ComplianceAs a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our medical devices comply with regulatory requirements worldwide. This involves supporting day-to-day regulatory activities, handling multiple projects related to regulatory compliance enhancements, and maintaining...
