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Search Results for Pharmaceutical
Job Title. Location Salary Actions

CMC Pre-Approval Regulatory Scientist

CMC Pre-Approval Regulatory Scientist Our client, a global pharma company, are currently recruiting for a CMC Pre-Approval Regulatory Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts.. As CMC Pre-Approval Regulatory Scientist, you will partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical and operational direction and support to expedite CMC development of the organisations portfolio by developing successful regul...

Location: Cork,
CMC Pre-Approval Regulatory Scientist
Cork Not Disclosed

Principal Scientist Global Regulatory Affairs CMC

Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration...

Location: Limerick,
Principal Scientist Global Regulatory Affairs CMC
Limerick Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client, a pharma organisation, are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis with hybrid working. Experience working with oral solid dosage (OSD) forms is essential for this role. You will work with a small team in Ireland and other team members across the UK and EU. Responsibilities Advise and liaise services on behalf of company to ensure that requirements of national competent authorities are met Create, assemble, review and publish regulatory submissions in accordance with agreed ...

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed

CMC Regulatory Principal Scientist

CMC Regulatory Principal Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration...

Location: Cork,
CMC Regulatory Principal Scientist
Cork Not Disclosed

CMC Regulatory Senior Scientist

CMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi...

Location: Cork,
CMC Regulatory Senior Scientist
Cork Not Disclosed

Regulatory Affairs - Complaints Co-Ordinator

AMC0010 Regulatory Affairs - Complaint Co-ordinator 6 month contract Hybrid - Dublin - D12 Product Complaints Coordinator Role Main tasks: Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures. Document and maintain the complaint files for reports received. Prompt communicati...

Location: Dublin,
Regulatory Affairs - Complaints Co-Ordinator
Dublin Not Disclosed

Associate / Sr Associate (Regulatory Labelling)

Associate / Sr Associate - Regulatory Labelling Our client is a global healthcare leader. Their 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 through philanthropy and volunteerism. They are looking for people who are determined to make life better for people around the world. For more than 140 years, they have worked tirelessly to discover medicines that make life better. They are currently seeking a Labelling Associate / Senior Labeling...

Location: Cork,
Associate / Sr Associate (Regulatory Labelling)
Cork Not Disclosed

Qualified Person

Qualified Person Our client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously. Responsibilities Ensure manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation Ensure that biotech drug product batches are test...

Location: Limerick, Limerick City,
Qualified Person
Limerick Not Disclosed

Manufacturing Engineer

My Client: My client are based in Bishopstown, Cork and have developed a breakthrough single-use medical device, Solo+ TTD that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear. The surgical tympanostomy is the most common procedure done on children. This company was crowned Seedcorn’s Overall Winner for the Best Early Stage Company in 2014 and Emerging Medtech Company of the Year, Irish Medical Device Association (IMDA) in 2015. The AventaMed team have successfully co...

Location: Cork,
Manufacturing Engineer
Cork Not Disclosed

Quality Manager

Job title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Quality Manager
EU Not Disclosed

Quality Systems Manager

Company: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager
EU Not Disclosed