Hot Regulatory Affairs Jobs

Pharmacovigilance Regulatory Affairs Advisor Fully Remote

Pharmacovigilance Regulatory Affairs Advisor-Fully remote Our client, a regulatory consultancy organisation are currently recruiting for a Pharmacovigilance Regulatory Affairs Advisor to join their team on permanent basis. This role is 100% home based. Responsibilities Creation & review, with strong emphasis on critical evaluation, of all clinical reports, efficacy & safety summary reports while working collaboratively with clients. Preparation of Risk Management Plans (RMP's), Signal Detection Reports, PSUR's with assessment of ...

Location: Republic of Ireland,

CMC Development Regulatory Associate

CMC Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding strategy develop...

Location: Cork,

Clinical Development Director (Oncology)

Our client is a global Biopharma who are establishing a Clinical Trials Centre of Excellence in Dublin, Ireland. They are seeking a qualified Medical doctor (essential), preferably with Oncology clinical trial experience, in the area of Haematology or a related therapeutic area. The successful person shall lead multiple components of clinical trial programs in paediatric oncology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you will be accountable for various aspects of ongoing clinical trial progra...

Location: Dublin,

Director of Regulatory Affairs

Our client a global medical device companywho have established a European Centre of Excellence in Ireland are currently seeking a Director of Regulatory Affairs to join their team. The Director of Reg Affairs will support worldwide regulatory submissions and audits outside of USA. The Director of Regulatory Affairs will report to VP of International Operations and will be a dynamic, detail-oriented, self-directed contributor and will spot opportunities to develop and optimize regulatory strategy while managing multiple projects and priorities. The Director of &nbsp...

Location: Galway,

Senior Regulatory Affairs

Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System Role/Responsibilities Manage the regulatory and vigilance process. Prepare regulatory submissions for required markets coordinating input from other stakeholders, tr...

Location: Galway,

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Pr...

Location: Dublin,

Quality Engineer-Operations

Quality Engineer – Operations Our client a high potential and fast growing medical device start up currently seeks a Quality Engineer to join their team. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks supporting the Operations function. Role/Responsibilities: Liaise with technical operations function to support the inspection and manufacturing activities at the OEM facility to ensure compliant product is consistently delivered. Develop and implement inspection proce...

Location: Galway,

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Provi...

Location: Dublin,

Clinical Publisher Associate

Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide...

Location: Cork,