Product Development / Clinical

Regulatory Documentation Specialist ( contract)

Regulatory Documentation Specialist (Dublin) This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Job Spec This contract regulatory-CMC role in an excellent opportunity to work for an Irish based biotechnology company that is in rapid growth and expanding its regulatory affairs team. The company produces a range of innovative products to treat a variety of health conditions. Reporting to the Director of CMC - Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, as the Regulatory Documentation Specialist, your key duties and responsibilities ...

Job Type:

Contract

Location:

South Dublin

Salary:

N/A

Job Ref:

N/A

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

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

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

Preclinical Project Manager (IND and CTA), Biotech

Preclinical Project Manager (IND and CTA), Biotech Our client, a young entrepreneurial and highly innovative start-up Biotech company, focused on developing small molecule therapeutics, now seek an Preclinical Project Manager to manage in late Preclinical stage development and IND process of a oncology product. The successful candidate will work on identifying and selection of suitable CRO(s), developing contract agreements and then providing oversight of all the responsibilities transferred by the development company to CROs and other vendors. This hire will operate from Dublin ideally but working remotely / will be considered for the right candidate. Also, workload will determ...

Job Type:

N/A

Location:

Dublin

Salary:

N/A

Job Ref:

123022