Quality

Head of Quality and Regulatory Affairs CMC

Director of Quality and Regulatory Affairs cmc Dublin Our client is a highly ambitious young US pharmaceutical company but with an impressive track record of building highly successful global businesses. Its strategy is to acquire marketed products and late stage development projects to expand portfolio. It seeks to selectively in-license or acquire FDA approved and late-stage development pharmaceutical products in focused therapeutic areas The Company’s management team has extensive experience in completing pharmaceutical transactions in a timely and collaborative manner, to the benefit of both parties. It has experience in a range of transaction structures including in-licensi...

Job Type:

Permanent

Location:

N/A

Salary:

N/A

Job Ref:

N/A

Director, Laboratory Operations

Director of Laboratory Operations Our client, a global pharmaceuticals manufacturer based in Connacht, now seeks a Director of Laboratory Operations who will be responsibility for all laboratory activities (Analytical and Microbiology labs) in support of all aspects of commercial, clinical and development activities. The Director of Laboratory Operations provides strong leadership, strategic planning, and laboratory system oversight for the site. The successful candidate will work collaboratively with the site leadership team to ensure the company strategic objectives are achieved. This hire will attend site leadership meetings ensuring effective implementation of site strategic...

Job Type:

Permanent

Location:

Connaght

Salary:

N/A

Job Ref:

122830

Quality Lead, Biologics

Quality Lead, Biologics Dublin Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drugs Primary Role: This role will serve as the lead for all Quality activities at the company Biologics manufacturing site in Ireland. The overall responsibility of this role is to design and execute the strategy for compliance to Good Manufacturing and Good Distribution Practices for all Irish operations in accordance to company global standards. Responsibilities include QA oversight and compliance of commissioning, qualification and validation activities during the development of the site. Responsible for establishing and hiring th...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

122794

Regulatory Affairs Manager

Regulatory Affairs Manager CMC, - Dublin Pharma The Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide. Activities including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items. Participate and support as an active member of a multi-disciplinary team to establish development and Regulatory CMC strategies for commercial products, late, and early stage development programs. Identify and communicate ...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

122884

Head of Quality and Reg Affairs cmc

Director of Quality and Regulatory Affairs cmc Dublin Our client is a highly ambitious young US pharmaceutical company but with an impressive track record of building highly successful global businesses. Its strategy is to acquire marketed products and late stage development projects to expand portfolio. It seeks to selectively in-license or acquire FDA approved and late-stage development pharmaceutical products in focused therapeutic areas The Company's management team has extensive experience in completing pharmaceutical transactions in a timely and collaborative manner, to the benefit of both parties. It has experience in a range of transaction structures including in-licensi...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

122875