Reference Number: JO-2108-474675
Job Type: Contract
12 month contract
Current remote working with long term flexibility to Surrey based office
Offering up to 45.00 per hour via an Umbrella solution
CPL Life Sciences is collaborating with the leading pharmaceutical organisation who require an experienced Regulatory Contractor to join their expanding and established team on a initial 12 month contractual basis. Within this opportunity you will be responsible for the management and maintenance of Market Authorisations and Clinical Trial Authorisations.
Job Responsibilities include;
– Manage and Submit Marketing Authorisation Application
– Manage and Submit MA Variation Applications
– National/MRP/Decentralised MAA
– Build personal expertise through management of specified products within one or more therapy areas.
– Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
– Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions
-Lead MRP submission review and planning where country is RMS, in conjunction with GRA strategist.
– Manage and Submit MA Renewal Applications
Candidate Requirements include;
– Life sciences or chemistry graduate to honours level or equivalent
– Masters Degree, Post Graduate Diploma or PhD preferred
– Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
– Computer literacy
– Excellent written and verbal communication skills
– Proven strength in analytical thinking
If this opportunity is of interest to yourself please forward your up to date CV to firstname.lastname@example.org.