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/IMPD development 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 materials for 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 regulatory correspondence (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 toCommercial, 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
- Support the 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: Contract
Job Skills: regulatory affairs, regulatory, associate, cta, maa, registration, post approval, contract, assistant
Contact Name: Tim Barratt
Website: -
Direct Application URL: -