Overview

Reference Number: JO-2003-448418
Senior Regulatory Operations Specialist
Rate: £62,100 – 63,900
Job Type: Permanent
Location: Dublin City Centre

Senior Regulatory Operations Specialist
Location: Ireland, Dublin
Permanent position
Salary: Up to 70,000 per annum (dependent on experience)
Job reference: JO-2003-448418

Regulatory Professionals are collaborating with a biopharmaceutical organisation to recruit for a Senior Regulatory Operations Specialist. In this position youll oversee all regulatory submissions, ensuring theyre at the highest quality as well as overseeing the effective and appropriate management for regulatory documentation. Other duties include;

– Manage the publishing for regulatory submissions covering the whole product portfolio
– Manage publishing activities for marketing applications in eCTD format
– Create and manage submission plans
– Provide oversight for the selection and management of any outsourced publishing and records management vendors
– Develop proposals for continuous improvement of internal systems and processes

Requirements
– 4+ years experience working within a Regulatory Operations position
– Ability to direct operational staff to achieve submission publishing timelines
– Expert knowledge of global regulatory submission standards
– Expertise with submission publishing tools (eCTD building tools
– Experience with publishing, validating, and submitting full marketing applications in CTD format for the US/EU

If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or Charlie.Harris@Regulatoryprofessionals.com.
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 recommendation will earn you 250 worth of vouchers *terms and conditions apply*

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