Regulatory Affairs Manager

Recruiter
Regulatory Professionals
Location
Hampshire
Salary
up to £70,000 - £80,000 p
Posted
02 Dec 2017
Closes
08 Dec 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Affairs Manager
Hampshire, UK
Salary: up to £70,000 - £80,000 per annum plus competitive benefits package
Job Reference: J31412

The Company:
Regulatory Professionals are working with a well-established pharmaceutical consultancy who provide drug development services to pharmaceutical and biotech companies on a global scale. They are looking for a Regulatory Manager to join their collaborative senior team and act as the regulatory lead on multiple technical projects.

Main Responsibilities:
* Lead regulatory professionals on a number of technical projects
* Prepare, review and submit regulatory submissions in compliance with the applicable SOPs and regulatory legislation
* Contribute to Clinical Trial Application submissions
* Compile and submit EU/Rest of World initial submissions and Post Authorisation Submissions (variations, renewals, etc.)

The ideal candidate will possess the following skills:
* A broad drug development background with experience working with CTAs
* Knowledge of Post Authorisation Submissions
* Minimum of 4 years regulatory experience
* In depth understanding of UK, EU and US markets - allowing for the provision of strategic advice

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you`ll receive £250 worth of vouchers of your choice.

Clinical Trial Applications, Drug development, strategy, MAA, EU, RoW, Hampshire, Wiltshire, Berkshire, Sussex, Surrey, project management, clinical development, Regulatory, Manager