Global Director of Regulatory Affairs

Next Generation

Dublin
Permanent
Full-time

13 days ago
Apply easily

Exciting Opportunity: Global Director of Regulatory AffairsCompany Overview: Our client, an expanding global biopharmaceutical company, is at the forefront of innovation in oncology therapeutics. With a commitment to improving patient outcomes, they are expanding their therapeutic portfolio and seeking a talented Global Director of Regulatory Affairs to lead their regulatory strategy.Position: Global Director of Regulatory AffairsLocation: Dublin (Hybrid)About the Role: As part of our client's expansion, they are seeking a Global Director of Regulatory Affairs to join their dynamic team. This pivotal role will focus on developing and implementing regulatory affairs strategy for their expanding oncology portfolio, including products in late-stage development and poised for commercial launch.Responsibilities:

Lead multiple projects across therapeutic areas and define regulatory strategy, plans, and objectives.
Provide guidance on regulatory mechanisms to optimize pediatric product development, including Orphan Drug, Fast Track, and accelerated approval.
Drive the development of a comprehensive regulatory strategy, incorporating worldwide regulatory requirements.
Collaborate with cross-functional teams in submission preparation and correspondence with Health Authorities.
Serve as the regulatory voice in strategic project team decisions and governance meetings.

Experience Required:

Degree qualified with 10-15 years of regulatory affairs experience, ideally across biopharma products.
Strong preference for experience in orphan drug development.
Extensive experience in commercialization and product launch is essential.

The Next Step for you:Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.Applications are in strict confidence.Next Generation will never share your data outside of our organisation without your prior written consent.Please read our Data Protection Policy on our website.

Next Generation