Senior Regulatory Operations Specialist

Senior Regulatory Operations Specialist
Location: Dublin (Relocation support offered)
Salary: Up to 90,000 per annum
Permanent position
Job reference: JO-2004-449509

Regulatory Professionals are collaborating with an expanding pharmaceutical organisation specialized in rare diseases, orphan drugs and Cell & Gene therapies. In this position you will be managing all publishing and submission activities across the portfolio and the development of internal processes. Duties include but not limited to;

Managing publishing activities for marketing applications in eCTD format; formatting, publishing, submitting, lifecycle activities, and archiving sequences
Providing oversight for the selection and management of any outsourced publishing and records management vendors
Managing document publishing for regulatory submissions from all areas of company
Developing proposals for continuous improvement of internal systems and processes
Requirements
Must have a relevant life sciences degree
Expert knowledge regarding global regulatory submission standards, software validation concepts, and publishing best practices
ability to work independently with moderate supervision
5+ years Regulatory operations experience focused on publishing and submissions activities.


If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or [email protected].
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful