Regulatory Operations Specialist - Pharmaceutical

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.