Associate Director Global Regulatory Affairs
10 hours 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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Director/Associate Director, Regulatory CMC
23 hours 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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[1/18/2025 A] Associate/ Sr. Associate
3 hours 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
3 hours 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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Sr. Associate/Manager
17 hours 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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Associate Director – Clinical Drug Supply
23 hours 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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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, Clinical Trial Program Lead
17 hours 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 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 Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
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Associate Director
23 hours ago
Cork, Ireland Cpl Resources Full timeAssociate Director Our clients advisory Financial Accounting division are a group of proactive accounting specialists who are focused on providing practical solutions to their clients complex financial reporting issues. The advisory team must be able to respond quickly to fast moving business processes and timelines whether assisting with advice related to...
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(Apply in 3 Minutes) Associate Director
17 hours 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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Associate Director
17 hours 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
3 hours ago
Cork, Ireland Life Science Recruitment Full timeSr. Associate - Quality for Computer Systems Validation A Computer Systems Quality Sr. Associate is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical...
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Director, Drug Product Technology Transfer
7 days ago
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
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Senior Associate
3 hours 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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▷ [Only 24h Left] Regulatory Analyst (with Arabic)
10 hours ago
Cork, Ireland Compliance & Risks Full timeJob Title: Regulatory Compliance Analyst with Arabic Language skills (Full Time) Reports to: Regulatory Compliance Manager Location: Cork, Ireland / Remote / Office / Hybrid About Us: Compliance & Risks is the leading provider of market access and product compliance SaaS solutions and is recognized as the leading end-to-end global product compliance...
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Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
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Project Director – Life Sciences
10 hours ago
Cork, Ireland HOMESTEAD PROPERTY MANAGEMENT SERVI Full timeAt Jacobs, we're challenging today to reinvent tomorrow by solving the world's most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good. Your impact At Jacobs, we'll...
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Associate/Sr. Associate
17 hours 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...
