Planet Pharma are partnered with a leading biotechnology company and we are actively seeking a Senior Associate Regulatory Affairs to join the business.
This is a predominantly remote role requiring experience in CTA submissions.
Key Responsibilities: Execute the regional regulatory strategy and regional regulatory plans.
Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.
Use of Amgen systems and document management.
Ensure and support regulatory product compliance.
Work with Policies and SOPs.
Build effective relationships and communication paths across local and functional organizations.
Enable efficiencies and seamless execution across the region countries.
Key Requirements: Bachelors/Masters Degree (scientific area) 2 years of direct relevant experience Clinical Trials experience preferred About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London.
We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field.
Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery.
We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com Please click 'apply' or contact Harry Banks (Recruiter II) at Planet Pharma for more information: E: ****** T: +44 20 3808 4810