Overview

Reference Number: JO-2005-450272
Senior Regulatory Operations Specialist
Rate: Negotiable
Job Type: Permanent
Location: United States

Senior Regulatory Operations Specialist
Location: California, US
Permanent position
Salary: Dependent on experience
Job reference: JO-2005-450272

Regulatory Professionals are collaborating with a pharmaceutical 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
– 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 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*