Reference: 07629 Job Type: Temp-to-Perm Date Posted: 22 February 2019
Job Type: Temp-to-Perm
Date Posted: 22 February 2019
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.
Want to earn up to £500? *
*Terms and conditions apply
- People centric organisation with a focus on excellence
- Pipeline focused on cell and gene therapy
- Global biotechnology company
- Strategic senior regulatory affairs role
- Working in conjunction with global stakeholders
- Dynamic and positive company growing consistently year-on-year
£22.00 to £23.00 per hour + Holiday Pay
- Working for a global pharmaceutical company
- Excellent opportunity to work for a company that truly value their employees
- Joining a fast paced, highly accurate and proactive team