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Executive Director, Biologics Development
Executive Director, Biologics Development Our client is a fast growing highly profitable multinational biopharmaceutical company with a large exciting pipeline of drug compounds at an advanced stage in research. This newly created role, will lead their Biologics development team. Job Spec This leadership position will lead the Biologics development team responsible for progression of the portfolio of biologics projects at various stages of the development life cycle from early development through commercialization and life cycle management. It will have responsibility for drug substance, formulation and drug product and bioanalytical development activities. Activities may be per...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- N/A
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Drug Development Director
Director of Product Development Our client is a young indigenous privately owned pharmaceutical company with an impressive track record of building highly successful global businesses. Its strategy to date has been 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 but also initiate its own development programs. 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 ...
- 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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Executive Director, Biologics Development
Executive Director, Biologics Development Our client is a fast growing highly profitable multinational biopharmaceutical company with a large exciting pipeline of drug compounds at an advanced stage in research. This newly created role, will lead their Biologics development team. Job Spec This leadership position will lead the Biologics development team responsible for progression of the portfolio of biologics projects at various stages of the development life cycle from early development through commercialization and life cycle management. It will have responsibility for drug substance, formulation and drug product and bioanalytical development activities. Activities may be per...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122982
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Regulatory Affairs, Associate Director
Regulatory Affairs, Associate Director (Dublin) This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Reporting to the Director of Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, the Associate Director of Regulatory Affairs will be responsible for developing regulatory strategies, and planning, managing and executing regulatory activities for investigational drug products in the EU & RoW. Job Spec Develop EU regulatory strategies and work with the Director of Regulatory Affairs and global Regulatory team towards the development of global...
- Job Type:
- Permanent
- Location:
- Dublin
- Salary:
- N/A
- Job Ref:
- 122956
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