Associate Director Global Regulatory Affairs
2 days ago
Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that reflects an end-to-end mindsetand demonstrates judgement-based decision making Actively coach and mentor staff, including providing strategic guidance to staff on regulatory andlabelling process questions Empower staff members to make logical decisions, resolve issues and execute tasks Manage workload based on portfolio prioritization and address implications to overall resourcemanagement and strategies Support and encourage a culture of innovation and model inclusivity to ensure diverse voices andideas are heard and considered Provide mentorship for the managers in the team and across the site Regulatory Delivery: Align regulatory/labelling strategy with molecule team priorities Actively seek out information on the needs of internal and external customers and monitor US andCanadian regulations Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and incompliance with regulatory and quality system requirements Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution Utilize regulatory and process knowledge to drive decision-making Partner with quality in both process improvements and deviation management Provide strategic guidance to staff on regulatory process questions Monitor regulations and the external environment as appropriate Provide technical, administrative and operational support for regulatory and labelling-related systems Requirements: Bachelors Degree, preferably in a scientific or health-related field Previous experience, preferably 5 years in a lead role in the pharmaceutical industry Must understand regulatory processes and the interdependencies of various tasks that requirecoordination among cross-functional team members and possibly third parties Experienced people manager Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspireothers Demonstrated flexibility and strong negotiation skills Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose rootcauses and take corrective actions to prevent reoccurrence Proven ability to coach and develop others For more information please contact Sinéad Cullen on or Skills: Regulatory Affairs People Management Regulatory Affairs Manager
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Associate Director Global Regulatory Affairs
2 weeks ago
Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a...
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Director/Associate Director, Regulatory CMC
2 weeks ago
Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Director/Associate Director, Regulatory CMC
2 days ago
Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Associate Director Clinical Regulatory Scientist
2 weeks ago
Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Clinical Regulatory Scientist(Paediatrics) Our client, a global pharma company are currently recruiting for an Associate Director Clinical Regulatory Scientist (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...
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Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Clinical Regulatory Scientist(Paediatrics) Our client, a global pharma company are currently recruiting for an Associate Director Clinical Regulatory Scientist (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...
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Associate Director
2 weeks ago
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...
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Cork, Ireland Life Science Recruitment Full timeAssociate Director Clinical Regulatory Scientist (Paediatrics) Associate Director Clinical Regulatory Scientist (Paediatrics) Our client, a global pharma company, is currently recruiting for an Associate Director Clinical Regulatory Scientist (Paediatrics) to join their team on a permanent basis. As Associate Director Clinical Regulatory Scientist, you will...
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Associate Director
4 days ago
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...
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Regulatory Affairs Specialist
2 weeks ago
Cork, Ireland Life Science Recruitment Full timeRegulatory Affairs Specialist (Remote/Hybrid) Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...
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[1/18/2025 A] Associate/ Sr. Associate
2 weeks ago
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...
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(Immediate Start) Associate Director
2 weeks ago
Cork, Ireland Eli Lilly and Company Full timeAssociate Director - Clinical Regulatory Scientist (Specialising in Pediatrics) Locations: Ireland, Cork Time Type: Full time Posted on: Posted 3 Days Ago Job Requisition ID: R-71384 At 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...
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Cork, Ireland Recordati Full timeRegulatory Affairs Manager International Sales ID: 1128 Date of Posting: Dec 12, 2024 Business Area: Regulatory Affairs Job Type: Direct Employee Location: Cork, IE Territory: Full-Time or Part-Time: Full Time Seniority: Mid-senior With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical...
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▷ 3 Days Left! Regulatory Scientist
2 weeks ago
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...
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Sr. Associate/Manager
2 weeks ago
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...
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Cork, Ireland BIOMARIN Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
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Associate Director – Clinical Drug Supply
2 weeks ago
Cork, Ireland Total Supply Corp Full timeAssociate Director – Clinical Drug Supply At 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...
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[1/24/2025 A] Associate
2 weeks ago
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...
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Cork, Ireland Life Science Recruitment Full timeSenior Director Statistics Data and Analytics Senior Director Statistics, Data and Analytics Our client, a global pharma company, is adding to their statistics team and is currently recruiting for a Senior Director Statistics, Data and Analytics to join their talented team, on a permanent basis. People management experience is essential for this role. This...
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Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
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Associate Director
11 hours ago
Cork, Ireland Morgan McKinley Full timeAbout the job Associate Director About The Client The company believe in going beyond the expected. We're a leading professional services firm with a global reach, committed to helping our clients navigate a complex business landscape. We value collaboration, innovation, and individual growth, offering a supportive and inclusive environment for our people....
