Vacancy summary
Reference: 06712 Job Type: Temporary Date Posted: 31 May 2017Vacancy summary
Get in touch
Suzanne Bessant
Consultant
01753 830706
Regulatory Operations Specialist – Temporary | 6 Months
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. We are seeking talented individuals who are ready to hit the ground running on an initial 6 month temporary contract and would thrive in joining this fast paced department.
Responsibilities will include:
- Aid the Regulatory Affairs team in preparation and submission of all INDS/NDAs/MAAs – life cycle management of all submissions using EDMS and electronic systems.
- Responsible for compiling, tracking, dispatching and archiving regulatory documents and submissions in both paper and electronic formats.
- Responsible for the development and publishing of major and routine global paper and electronic submissions; including MAAs/NDAs, INDs, DSURs, PIPs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, Briefing Books, etc.
- Working with functional source areas to ensure documents are compliant.
- Maintain all Regulatory and FDA correspondences.
Candidate:
- Bachelor’s Degree or equivalent experience.
- Previous working experience in both Regulatory Operations and the Pharmaceutical industry.
- Paper and electronic knowledge of IND, NDA, MAA, CTA requirements and guidelines.
- Experience working with Electronic Document Management Systems (EDMS) and publishing eCTD using electronic publishing systems.
- Knowledge of industry trends regarding electronic submissions would be advantageous.
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 know more?
Want to earn up to £500? *
*Terms and conditions apply
Similar jobs to consider
-
CMC Regulatory Affairs Associate
£14.00 per hour + Holiday Pay
Uxbridge
Temporary
- 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
Read more
-
Senior Regulatory Affairs Manager
£45.00 to £47.00 per hour + Holiday Pay
Uxbridge
Temporary
- Working for a global pharmaceutical company
- Excellent opportunity to work for an innovative company at the forefront of their therapy area
- Working as a regulatory lead on a product
Read more
-
Regulatory Affairs Lead
Negotiable
Uxbridge
Permanent
- Working for a global pharmaceutical company
- With an innovative outlook, they have exciting growth plans for the UK & Ireland business
- Career growth potential
Read more