My client, a highly successful biopharmaceutical company, is looking for a Senior Associate, Regulatory Affairs on an initial 12 month contract. The focus will be towards pre-filing activities.
The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA submission (national or VHP)/IMPD generation and updates. Accountable for the generation and maintenance of regional CTA application dossier in collaboration with Regional Regulatory Lead.
Create and maintain product regulatory history documents through RIM (Regulatory Information and Management System) and appropriately archive all regulatory documents and agency communications for clinical trial applications in eTMF. Review regional component of the Global Regulatory Plan and provide input to operational deliverables.
Maintain ongoing clinical trial activities via protocol amendments, IB updates etc via completing assessment for reportability (Substantial and non-substantial amendments and urgent safety measures). Complete all end of trial activities in line with GCP, country requirements and company standard operating procedures. Collaborate with regional affiliates to provide submission components for national or VHP clinical trial applications.
Representation in study meetings and contribute as function expert to ensure compliance and drive study team objectives. Organise and generate response to clinical trial related questions to address agency raised GNAs. Responsible for safety reporting of ongoing clinical trials as required.
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 (related to clinical trial applications). Provide primary authorship to routine regulatory correspondence for CTAs. 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,).
Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams for CTA related activities. Actively support regulatory compliance Support the development and execution of GRT goals Key Skills Strong communication skills - oral and written Organizational skills Understanding EU clinical trial application process and requirements set out as per GCP and EudraLex - Volume 10. Accustomed to leading National or VHP new CTA submission while providing regional preferences to meet study team goals.
If you would like further information, please get in touch with Ross Wilson at email@example.com for further information.
You must be eligible to work in the UK. Learn more
- Agency: Key People
- Reference: 89069
- Posted: 5th October 2020
- Expires: 2nd November 2020