Job Description
Lead the Next Wave of Advances in Immuno-Oncology
Reporting to the US based Vice President of Global Regulatory Affairs, this is an exciting opportunity for an ambitious and talented regulatory professional wanting to contribute in a meaningful way to the development of innovative IO drugs for cancer patients. Our client offers a unique opportunity to work in a science-driven, dynamic, human?sized, respectful and professional environment.
Job Spec
Provide regulatory support for all company products including managing regulatory interactions and clinical trial applications in Europe and International countries. Advise on regulatory strategies from EU perspective (act as the EU regulatory expert). Coordinate all aspects of regulatory submissions, including:
- Develop and manage regulatory project timelines.
- Provide regulatory guidance on requirements for CTA filings.
- Coordinate preparation of regulatory documentation (CTAs, meeting materials, briefing books, DSURs, orphan drug designations, paediatric investigational plans, etc.).
- Approve relevant submissions and components (e.g., labels).
- Coordinate response to Agency’s queries.
- Oversee, manage and coordinate the regulatory collaboration with the CROs and partner organizations.
- Participate as a regulatory representative at relevant teams (e.g., Clinical Operations, Project Teams) advising on submission preparation timelines, processes and requirements.
- Monitor and evaluate the European regulatory affairs environment. Maintain an awareness of current and future risks that may impact business.
Person Spec
The preferred candidate will be degree qualified within a relevant scientific discipline, will enjoy a track record of success 10 + years’ experience in EU Regulatory Affairs. You will bring a depth of expertise in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non-Clinical). ROW experience is a plus
You will possess high detail orientation with the ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills. Effective collaborator who can bring together multiple stakeholders and able to build positive relationships, with both internal and external partners. Change-Agility needed, a mindset who can thrive in a dynamic, complex, and regulated environment.
Cv to gerry@rftgroup.ie