Regulatory Affairs Manager
My client a global Clinical Research Organisation has opened a new vacancy within their Regulatory Function.
They are actively seeking to recruit a Regulatory Affairs Manager to their team on a permanent basis in Berkshire, UK.
· Be Responsible for UK Regulatory Submissions, including CTA’s, IMPD’s, EC Submissions.
· Submissions of Protocol amendments and Investigator brochure updates.
· Provide General Regulatory guidance of junior team members.
· Responsible for Developing and implementing Regulatory Strategies.
· Providing guidance on compliance issues.
· Keeping upto date with changes in local Regulatory Legislation.
· Working closely with other internal departments to assure timely submissions of regulatory documents.
· Life Sciences Degree.
· Minimum 3 Years’ experience within Regulatory Affairs, ideally within a Clinical Research background.
· Excellent understanding of GCP-ICH Guidelines.
· Familiar with the UK Regulatory Market.
· Fully eligible to work in the UK.
For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070