Product Development / Clinical

Regulatory Affairs Manager

Regulatory Affairs Manager We are recruiting an additional Regulatory Affairs Manager for our clients rapidly growing Global Regulatory Affairs team located in Dublin. The Dublin team provide regulatory operations and strategy support to their current and growing product portfolio, therapy areas and international market presence. Job Spec Acts as responsible Senior Regulatory Team member for assigned regulatory projects Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and \ or updates as required. Prepares and/or reviews regulatory documenta...

Job Type:

Permanent full-time

Location:

Dublin

Salary:

N/A

Job Ref:

N/A

Clinical Programming, Associate Director

Clinical Programming, Associate Director Our client is a fast growing highly profitable multinational biopharma company with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created role of Associate Director, Clinical Programming based in their Dublin office. This role will report to the Head of Clinical Programming based in their US office. The ideal candidate will be experienced in clinical programming data (SDTM, ADaM, clinical data checks, demographic summary table) and SAS TFL programming. Clinical Study Lead experience and strong project / people management skills are highly desirable. The successful candidate will establish the Cli...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

123244

Clinical Project Manager

Clinical Project Manager Our client, a growing commercial pharmaceutical company based in Dublin, now seeks a Clinical Project Manager to manage the day to day activities of the clinical studies. This hire will work directly with both internal and external stakeholders to ensure timely and high-quality delivery of the ongoing clinical trials. The successful candidate will work with the CRO to drive the scope of service agreements, budgets, plans and detailed timelines, ensuring that performance expectations are met. Person fit: Ideal candidate will be; a dynamic individual, who is self-driven and capable of working on their own initiative in a start-up environment. This hire mus...

Job Type:

Contract

Location:

Dublin

Salary:

N/A

Job Ref:

123202

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

Drug Development Director

Director, Drug Development Dublin pharma Ambitious Drug Development expansion plans have led to the establishment if this exciting management position. This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young company. Job Spec: The Director, Drug Development works on directing the technical activities for company product development programs. The activities may be performed by partners, contractors or company personnel. The range of technologies used for products that he/she manage will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, p...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

123304