Job Reference: BBBH22381
Job Duration: 12 months
Start date: a.s.a.p
Description:
Within this role you will assist with, under the direction of a Regional Regulatory Lead, the creation and submission of regulatory documents and you may be the regulatory lead for a program under the supervision of a more experienced regulatory lead!Responsibilities:
-Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPDdevelopment and submission, support for pre-MAA filing, regulatory authority meeting preparations)
-Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
-Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
-Review regional component of the Global Regulatory Plan and provide input to operational deliverables
-Ensure compliance via timely submissions to regulatory agencies
-Support RRL in review of promotional materialsfor commercial activities (ex-US)
-Collaborate with CROs / partners to support site initiation
-Coordinate collection of functional documents in support of regulatory applications
-As appropriate participate in GRT to support execution of regulatory strategy
-Coordinate QC of regulatory documentation (e.g. briefing packages)
-Provide primary authorship to routine regulatorycorrespondence (e.g. annual reports, investigator packages)
-Prepare regulatory packages and cross-reference letters to support investigator initiated studies
-Approve drug shipment for the company and Investigator Initiated Studies
-Complete regulatory forms to support agency communications (E.G. EudraCT,)
-Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
-Support process improvement initiatives,standards development, and metrics
-Assist in template development and maintenance
-Respond to specific requests from and communicate relevant issues to GRT
-Develop Regulatory Position with teams
-Actively support regulatory compliance
-Supportthe development and execution of GRT goals
Key Skills
-Strong communication skills - oral and written
-Organizational skills
-Understanding of drug development process
For further details, please contact Tim Barratt on +441727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: £20 - £25 per hour
Salary Benefits:
Vacancy Type: Permanent
Job Skills: regulatory affairs, regulatory, associate, cta, maa, registration, post approval, contract, assistant
Contact Name: Tim Barratt
Website: -
Direct Application URL: -