Regulatory Affairs Manager
Regulatory Affairs Manager / Senior Manager
We are currently assisting a Bio-pharmaceutical company who have an excellent opportunity available for a highly experienced Regulatory Affairs Manager. This company is a global pharmaceutical manufacturer with a strong focus on R&D covering different therapeutic areas. The position will be focused on a high profile rare disease product which they are looking to get marketed in the not so distance future.
Defining project and product regulatory strategy in line with commercial and company strategy, consulting with appropriate departments when necessary
Provide expert regulatory advice to other departments in the organisation, and regulatory support to licensing partners in the EU and other territories
Ensure communication of changes in business-critical legislation/regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner
Pro-actively identify potential obstacles to approval of regulatory submissions and manage the resolution of issues
The ability to understand and present complex scientific arguments
5+ years Regulatory Affairs experience
Excellent negotiation, verbal and written communication and interpersonal skills
The ability to think strategically and develop global regulatory strategy whilst balancing local/affiliate needs
Prior experience working with NCE or Orphan Drugs is essential
Previously worked MAAs.
If you are interested in this role please email your CV to *********************************** or call Charlie Harris on ************ to discuss further.
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you 250 in vouchers of your choice.
This job was originally posted as www.emedcareers.com/job/960518939