One of my biggest clients within the pharmaceutical market in the UK is looking for someone to join their Regulatory Team!!
Job title: Regulatory Professional
Location: Uxbridge (possibility to WFH)
Contract: 12 months (Inside IR35)
- Creation and submission of regulatory documents and 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/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
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Collaborate with CROs / partners to support site initiation
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Strong communication skills - oral and written
- Understanding of drug development process
Michael Bailey International is acting as an Employment Business in relation to this vacancy.