Location: Dublin, Ireland
Salary: Flexible dependant on experience, offering an extensive benefits package (car allowance, shares, short term incentives)
Permanent position
Reference: JO-2101-460435
We have an exciting opportunity available with an expanding biopharmaceutical company based in Dublin. In this role, you will be responsible for providing technical and strategic leadership for paediatrics products in development. For the correct applicant, this would offer an opportunity to build/manage a team & to play a leading role within the company’s strategic plans for the paediatrics department.
Responsibilities include
- Providing regulatory guidance on the development of global paediatric submissions the US and EU.
- Prepare and/or manage others’ submissions that are technically complex
- Updating and preparing the Company for major changes in paediatric legislation in assigned territories
- Developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Leading one or more teams to prepare for submissions
Experience
- 10+ years’ experience working within Regulatory Affairs
- Degree in a scientific field
- Extensive knowledge of paediatric regulatory requirements & understanding of current global/regional trends in Regulatory Affairs.
- Ability to manage multiple projects and a small team
- Experience working with the US and EU is highly beneficial
If you would like to apply for this position or discuss any of our other active positions please contact Charlie on Charlie.harris@cpl.com or https://www.linkedin.com/in/charlie-harris-5b2992ba/
