Regulatory Operations Submission Specialist ¦ Uxbridge

Regulatory Operations Submission Specialist ¦ Temp to Perm ¦ Uxbridge

A global pharmaceutical company based in Uxbridge, are looking to recruit a dynamic Regulatory Operations professional to work alongside their established Regulatory and Compliance teams. This role is focused on the regulatory submission process so having exposure to creating and publishing regulatory dossiers (eCTD and NeeS formats) is essential.

We are seeking talented individuals who are ready to hit the ground running on an initial temporary contract but who are comfortable transitioning over to a permanent contract on a long-term basis.  

Responsibilities will include:

• Working closely with the Regulatory Operations Leads in the creation and submission of all INDS / NDAs / MAAs & 510Ks
• Take ownership for compiling, tracking, dispatching and archiving regulatory documents and submissions in both paper and electronic formats (eCTD and NeeS)
• Typical regulatory documents will include annual reports, periodic safety reports, DSUR Supplements, Variations, Renewals, Briefing Books, etc.
• Working with functional source areas to ensure documents are compliant (CMC, regulatory, clinical and non-clinical)
• Maintain all Regulatory and FDA correspondences

What background will make you successful in this role:

• Bachelor’s Degree or suitable equivalent experience
• Previous working experience in both Regulatory Operations with the pharmaceutical industry
• Paper and electronic knowledge of IND, NDA, MAA requirements and guidelines
• Solid experience with Electronic Document Management Systems (EDMS) and therefore, creating and compiling eCTD submissions in a publishing tool
• A high attention to detail and strong time management skills

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.