The Role: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 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/IMPD development and submission, support for pre-MAA filing)
- 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 and support RRL in review of promotional materials for commercial activities (ex-US)
- Collaborate with CROs / partners to support site initiation and coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy and 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 Company and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,)
- Support process improvement initiatives, standards development, and metrics
- Minimum graduate level, in any life sciences.
- EU experience, regional level rather than affiliate level
- Preparing and submitting CTAs applications. It would be a bonus if they have used the VHP.
- Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products.
- 3 years' experience
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.