Can you demonstrate extensive Regulatory Affairs experience in Pharmaceutical or Biological products? Are you experienced in negotiating with regulatory authorities at both product and strategic level? Do you have knowledge of EU regulatory procedures and dossier requirements with specific emphasis on generic applications?
If your answer is YES to the above, we may have the ideal opportunity for you!
We are delighted to be supporting one of the largest pharmaceutical contract development manufacturing organisations in the world with the appointment of an experienced Head of Regulatory Affairs.
Who are we looking for?
A strategic individual to provide regulatory guidance and coordination of the pharmacovigilance oversight activities.
What will you be doing?
- Lead, develop and implement regulatory strategy in order to meet corporate goals and objectives
- Lead and participate in the planning, preparation and delivery of submissions throughout the product's life cycle including briefing documents, INDs, CTAs and annual reports
- Maintain products regulatory compliance
- Provide regulatory oversight and guidance to project teams
- Take a place on the management team, responsible for delivering the operating company business plan
The experience you will bring
- High level Scientific degree
- 10+ years of Regulatory Affairs experience
- Proven experience with the development of regulatory strategies for new products with specific emphasis on generic drug development in the EU
- Knowledge of and experience with FDA ANDA and 505(b)2 submissions considered as a plus
- Good knowledge of quality and pharmaceutical development
This position has the potential to be fulfilled remotely.