Specialist, Regulatory Affairs, Rare Diseases

The Opportunity The Regulatory Affairs Specialist, Artwork Labelling  is responsible for supporting product commercialization, for GPN owned and contract brands, for all activities involving regulatory compliance from concept to launch. This role will play a critical role in delivery of the growth objectives of the EMEA region.  Ensuring Product...

Description Director, Global Regulatory Affairs, Pediatrics Dublin, Ireland At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower...

When our values align, there's no limit to what we can achieve.   We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist , you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and...

We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. In this role, a typical day might include the following: Contributes to the management of the regulatory submission form process,...

When our values align, there's no limit to what we can achieve.   Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong...

RecruitNet International Ltd is specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through the professional registration, job placement, visa and employment permit processing.We are hiring  Clinical Nurse Specialist, Inflammatory Bowel Disease  into a Private Hospital in Dublin, Ireland.We will provide...

McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...

When our values align, there's no limit to what we can achieve.   We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...

The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Amsterdam office. The role is positioned at the Associate Director level to enable independent working and leadership in direct...

Regulatory Affairs Director- Dublin or Letterkenny/ Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and innovation,...

Regulatory Affairs Director- Dublin or Letterkenny/ Hybrid  As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.   With a strong ecosystem of investment and...

When our values align, there's no limit to what we can achieve.   We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country...

VP, Global Regulatory Affairs Consulting Services/ Ireland ,UK, Spain, Poland / Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an...

PTSB is one of Ireland's leading retail and SME banks, with an innovative range of products and services powered through an evolving digital landscape, our focus is centred on ensuring we deliver what our customers, colleagues and communities need to be successful. An excellent career opportunity has arisen within the Compliance Team for an Upstream...

Job DescriptionKEY RESPONSIBILITIES:Leads end-to-end Medical Strategy in global and international (mainly EU) projects. This includes sourcing and leveraging scientific studies and clinical data; crafting strategic medical narratives, and developing high-quality scientific content for promotional and educational activities, ensuring all deliverables comply...

Description Overview This role focuses on substantiation and management of safety and health benefit claims for new and established brands and products within the CSCI OTC organisation. The Scientific Affairs Manager leads on proving efficacy to drive competitive claims throughout product lifecycle and partners with Product Developers to develop superior...

ATC is a European logistics, white glove, and technical services specialist for data centres. Our focus is on anticipating the critical needs of our clients and delivering industry-leading standards for safety, security and reliability. Since being established in 1979, we have continued to lead our dedicated teams across Europe to build strong relationships...

PTSB is one of Ireland's leading retail and SME banks, with an innovative range of products and services powered through an evolving digital landscape, our focus is centred on ensuring we deliver what our customers, colleagues and communities need to be successful. This is a 10-month Fixed Term Contract within the Operational Resilience team. Operational...

 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the...

SUMMARY: The Manager, Regulatory Submission Project Management will be responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to postmarketing. The incumbent will report to the Sr Mgr Regulatory Submission Project Management and serve as the Reg PM lead for assigned therapeutic area (TA) and...