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Regulatory Affairs Director
Regulatory Affairs Director, Dublin pharma Our client is a young exciting ambitious biopharmaceutical company with an exceptional newly-created opportunity for a bright capable Regulatory Affairs Manager Position: The Director of Regulatory Affairs is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned commercial products, life cycle management initiatives and acquisitions including global regulatory strategy, regulatory submissions, and interaction with regulatory authorities. Responsibilities: Provides regulatory leadership to cross-functional teams, ensuring cross-functional perspective/expertise is incorporated in ...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- N/A
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Regulatory Affairs Associate Director / CMC Manager
Regulatory Affairs Associate Director / Manager CMC, - Dublin Pharma The Associate Director / Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide. Job Spec : 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 ...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122844
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Technical Operations Lead, Biopharma
Technical Operations Lead, Biopharma Our client is an exciting fast-expanding indigenous consulting and technology company specialising in developing innovative solutions for the development, scale-up, transfer, manufacture and supply of products in the global biopharmaceutical and medical device sectors. With a growing niche clientele comprising multinational companies, rapid expansion has led to a newly created senior role for a biopharmaceutical technical lead who will play a key role in the development of the company. Initially, the candidate will be a senior leader with responsibility for programme management of various pharmaceutical projects across; NPI, product launches,...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122953
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Regulatory Affairs Director
Regulatory Affairs Director, Dublin pharma Our client is a young exciting ambitious biopharmaceutical company with an exceptional newly-created opportunity for a bright capable Regulatory Affairs Manager Position: The Director of Regulatory Affairs is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned commercial products, life cycle management initiatives and acquisitions including global regulatory strategy, regulatory submissions, and interaction with regulatory authorities. Responsibilities: ? Provides regulatory leadership to cross-functional teams, ensuring cross-functional perspective/expertise is incorporated i...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122943
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Clinical Trial Manager, EU region
Clinical Trial Manager, EU region Our client is focused on the discovery, development and commercialization of novel antibodies that are directed towards rare diseases. Rapid expansion has led to the need to create the appointment of an EU-based Clinical Trials Manager, to be based in their Dublin office and operate as part of a global team. This is a rare opportunity to join a young, exciting clinical-stage biotechnology company who are growing year on year. Please note: this is an initial 12 month contract role. Candidates must be willing to travel circa 20 - 25% of the time, within EU region. The main focus of this role: is to work closely with various internal team members a...
- Job Type:
- Contract
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122933
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