Regulatory Affairs Manager
6 days ago
JOB DESCRIPTION FORM
Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.
Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.
The role & Responsibilities:
- Take lead role and responsibility for the effective planning, execution, tracking and reporting of assigned operational registration and life-cycle management projects for company Products.
- Promote high quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning and delivery of GRA and Corporate projects.
- Maintain a positive approach and attitude in a global multi-stakeholder company to help deliver high quality and timely registrations.
- Support corporate growth and patient treatment options.
- Line Management of more junior team members (internal and external).
- Acts as responsible Manager in the Regulatory Team member for assigned regulatory projects.
- Effectively plans, manages, and delivers assigned project workload.
- Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, publishing, CMC authoring and/or updates as required in line with corporate needs and timelines.
- Effective high-quality communication with Regulatory Authorities and internal BH functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
- Effective high-quality communication with external partners on an ad hoc basis.
Qualifications & Experience:
- Pharmacy or Scientific Primary and/or advanced Degree(s).
- >5 years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).
- Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling Experts.
- Experience of EU DCP and MRP MAAs.
- Project management experience.
- Excellent communication skills.
For full details please email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701
Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.
www.thornshaw.com
#LI-TD1
#J-18808-Ljbffr-
Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeRegulatory Affairs ManagerMy client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than...
-
Regulatory Affairs Manager
9 hours ago
Dublin, Dublin City, Ireland Robert Walters Ireland Full timeRegulatory Affairs ManagerWe are looking for a Regulatory Affairs Manager to join our team at Robert Walters Ireland. This exciting opportunity involves ensuring compliance with regulatory requirements, handling complaints efficiently, and maintaining ISO certification standards.The ideal candidate will have a background in data privacy, regulatory...
-
Regulatory Affairs Manager
2 days ago
Dublin, Dublin City, Ireland 360 Search Full timeJob Title: Regulatory Affairs ManagerA senior Regulatory Affairs Manager is sought for a reputable Financial Services Intermediary Firm in Dublin. Reporting to the Managing Director, this role involves overseeing compliance functions, assessing regulatory risks, and ensuring adherence to Central Banks Codes of Practice.Key Responsibilities:Ensure overall...
-
Regulatory Affairs Expert
2 days ago
Dublin, Dublin City, Ireland Camden Recruitment Partners Full time**Regulatory Affairs Expert Wanted**Camden Recruitment Partners is supporting a reputable Asset Management firm in Dublin in their search for a seasoned Regulatory Affairs Expert. This role requires an individual with expertise in regulatory affairs and risk management to contribute to the firm's risk assessment and mitigation strategies.Main...
-
Regulatory Affairs Manager
5 days ago
Dublin, Dublin City, Ireland Legal & General Full timeWe're looking for an experienced Regulatory Affairs Manager to join our team at Legal & General. As a key member of our Compliance Function, you will be responsible for providing a comprehensive business-focused compliance service to our company, Boards of Directors, and staff across Europe.In this role, you will be responsible for advising on regulatory and...
-
Regulatory Affairs Leader
5 days ago
Dublin, Dublin City, Ireland Emergent Biosolutions Full timeAt Emergent BioSolutions, we offer an exciting opportunity for a highly skilled Regulatory Affairs Leader to join our team. This key role will oversee regulatory activities across our product portfolio, ensuring compliance with EU and global regulations.The ideal candidate will have a strong background in regulatory affairs, with experience in biotechnology...
-
Regulatory Affairs Manager
5 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Regulatory Affairs Manager - CMC biologics (various European locations), DublinClient:ParexelLocation:Dublin, IrelandJob Category:OtherEU work permit required:YesJob Reference:0429b5e35894Job Views:8Posted:15.03.2025Expiry Date:29.04.2025Job Description:When our values align, there's no limit to what we can...
-
Senior Regulatory Affairs Manager
2 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCompany OverviewCpl Healthcare is a leading provider of healthcare staffing solutions, working with some of the world's most renowned healthcare organizations.Job DescriptionWe are seeking an experienced Senior Regulatory Affairs Officer to join our team in Dublin. As a key member of our regulatory affairs team, you will be responsible for managing marketing...
-
Regulatory Affairs Director
6 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJob Description:Cpl Healthcare on behalf of their client, a global pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Dublin.This full-time/hybrid position reports to the Global Regulatory Affairs Associate Director and involves taking a lead role and responsibility for planning, executing, tracking, and...
-
Regulatory Affairs Manager
1 day ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Regulatory Affairs Manager - CMC biologics (various European locations), remote, IrelandClient:ParexelLocation:Various European locationsJob Category:OtherEU work permit required:YesJob Reference:d5f1ae3ac7e2Job Views:1Posted:02.04.2025Expiry Date:17.05.2025Job Description:When our values align, there's no limit to...
-
Regulatory Affairs Expert
3 days ago
Dublin, Dublin City, Ireland CPL Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Dublin. As a key member of our global regulatory affairs team, you will be responsible for the effective planning, execution, tracking and reporting of assigned operational registration and life-cycle management projects for our company's products.
-
Regulatory Affairs Specialist
24 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl Healthcare is collaborating with a global pharmaceutical company to offer a new opportunity for a Regulatory Affairs Officer to join the Dublin team.The ideal candidate will possess life science qualifications and 2-3 years of experience in regulatory affairs, particularly knowledge of EU procedures (DCP, MRP). They must be able to multitask, communicate...
-
Regulatory Affairs Specialist
5 days ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeAbout the RoleQuanta Consultancy Services Ltd is seeking a highly skilled and experienced Regulatory Affairs professional to lead their Global Regulatory team. The ideal candidate will have a deep understanding of HPRA BoH requirements and experience in managing Market Authorisations filing.Key ResponsibilitiesRegulatory Affairs Expertise: Develop and...
-
Regulatory Affairs Manager
3 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: Take lead role and responsibility for the...
-
Regulatory Affairs Manager
6 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: To take lead role and responsibility for...
-
Regulatory Affairs Consultant
7 days ago
Dublin, Dublin City, Ireland IQVIA Full timeIQVIA Regulatory Affairs Consultant in Dublin, IrelandJoin Our Team: Regulatory Affairs ConsultantAre you a skilled Regulatory Affairs professional with strong technical knowledge and experience in the pharmaceutical industry? We are seeking an exceptional Regulatory Affairs Consultant to support our client's growing portfolio of niche, value-added products...
-
Regulatory Affairs Consultant
1 week ago
Dublin, Dublin City, Ireland IQVIA LLC Full timeRegulatory Affairs Consultant page is loadedRegulatory Affairs ConsultantApply locations Dublin, Ireland Roscommon, Connaught, Ireland time type Part time posted on Posted Yesterday job requisition id R1475082Join Our Team: Regulatory Affairs ConsultantAre you a skilled Regulatory Affairs professional with strong technical knowledge and experience in the...
-
Regulatory Affairs Officer
2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeRegulatory Affairs Officer & Senior Regulatory Affairs OfficerThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also have Senior Regulatory Affairs Officer opportunities.Key Responsibilities:Manage EU marketing...
-
Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland GxP Recruitment Full timeIn this role you will be in charge of managing teams within the Regulatory Affairs Sub-Function.Focus is on policy and strategy implementation and control rather than development and you will typically handle short-term operational/tactical responsibilities.As the Manager of the Regulatory Affairs Sub-Function, you will be responsible to:Oversee the strategy...
-
Regulatory Affairs Manager
4 weeks ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeThornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...