Associate Director, Regulatory Affairs
3 weeks ago
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 interactions with EU Regulatory agencies and with our business partners. This role will be focused on supporting development activities and developing teams in the area of cardiovascular, metabolic and allergic diseases. What a typical day might look like; Lead, handle and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team. Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required. Assist Development teams in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products. Responsible for leading MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling. Execute clinical trial applications for assigned programs and provide leadership for team members responsible. As needed, support activity with Business Partners to ensure the EU regulatory strategy meets Regeneron's business objective. Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate). Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required. Ensure emerging issues are flagged to EU regulatory leadership in a timely manner. This role might be for you if you have: Advanced degree in a scientific field. 8+ years regulatory experience with a focus on supporting products through clinical development. Experience of leading and developing staff members. Consistent record of supporting EU Clinical Trial Applications through approval and study start up. Experience in dealings with the EMA (scientific advice, orphan designation, PIPs). Experience of bringing a product through EU approval is a distinct advantage. Ability to negotiate and concisely express clear positions to stakeholders. Experience of directly working with national regulatory agencies and leading agency meetings face to face. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
-
Director, Global Regulatory Affairs, Pediatrics
5 months ago
Dublin, Ireland Gilead Sciences Ireland UC Full timeDescription 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...
-
Principal Regulatory Affairs Consultant
2 months ago
Dublin, Ireland Parexel Full timeWhen 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...
-
Dublin, Ireland UnitedHealth Group Full timeRegulatory 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,...
-
Dublin, Ireland Optum Full timeRegulatory 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...
-
Manager, Regulatory Affairs CMC
3 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeWe 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,...
-
Senior Regulatory Affairs Assistant
4 months ago
Dublin, Ireland Viatris Full timeMcDermott 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...
-
Regulatory Affairs Specialist, Artwork Labelling
4 months ago
Dublin, Ireland Glanbia Full timeThe 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...
-
Dublin, Ireland Chiesi Group Full timeWho we are looking for Purpose Join regulatory affairs in Rare Diseases Area! Be part of a dynamic, impactful field where every decision brings life-changing therapies closer to patients in need Main Responsibilities Under guidance of the regional Head, prepares, compiles, and maintains regulatory documents to support a broad...
-
Senior Regulatory Affairs Manager
2 months ago
Dublin, Ireland Parexel Full timeWhen 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...
-
Digital, Associate Director
3 months ago
Dublin, Ireland Teneo Full timeAbout Teneo Teneo is the global CEO advisory firm. We partner with our clients globally to do great things for a better future. Drawing upon our global team and expansive network of senior advisors, we provide advisory services across our five business segments on a stand-alone or fully integrated basis to help our clients solve complex business...
-
Dublin, Ireland Parexel Full timeWhen 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...
-
Dublin, Ireland ICON Clinical Research Limited Full timeVP, 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...
-
PA to Corporate Affairs Director
1 week ago
Dublin, Ireland Primark Full timeJob Description Personal Assistant Reporting to the Corporate Affairs Director Because we strive to put people first. Culture, our way. What’s a career at Primark all about? The positive impact you’re making, the experiences you’re having and the people you’re with....
-
PA to Corporate Affairs Director
2 weeks ago
Dublin, Ireland Primark Full timeJob Description Personal Assistant Reporting to the Corporate Affairs Director Because we strive to put people first. Culture, our way. What’s a career at Primark all about? The positive impact you’re making, the experiences you’re...
-
Manager, Scientific Affairs
4 months ago
Dublin, Ireland Perrigo Full timeDescription 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...
-
Regulatory Manager
7 months ago
Dublin, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...
-
Associate Director of Validation
4 months ago
Dublin, Ireland Grifols Full timeThe Associate Director of Validation will lead and support the qualification and compliance readiness of our new global center for the warehousing, processing, packaging, and worldwide distribution of human blood plasma and plasma derivatives for therapeutic use. The Associate Director of Validation will be responsible for direct leadership over the...
-
Associate Director
3 weeks ago
Dublin, Ireland Elevate Partners Full timeJob DescriptionWe have partnered exclusively with a Private Equity firm, focused on SME investments, to appoint an Associate Director/Director to its Dublin investment team. You will become a key member of the investment team and lead on both origination and execution efforts.THE ROLE:Lead and execute investment strategies with a focus on SME businesses,...
-
Associate Director
3 weeks ago
Dublin, Ireland Elevate Partners Full timeWe have partnered exclusively with a Private Equity firm, focused on SME investments, to appoint an Associate Director/Director to its Dublin investment team. You will become a key member of the investment team and lead on both origination and execution efforts.THE ROLE:Lead and execute investment strategies with a focus on SME businesses, including deal...
-
Regulatory Intelligence Specialist
4 weeks ago
Dublin, Ireland Parexel Full timeWhen 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...
