Reference Number: JO-2003-448338
Senior Regulatory Operations Specialist
Job Type: Permanent
Location: Dublin City Centre
Role: Senior Regulatory Affairs Operations Specialist
Employment: Permanent, Full Time
Our client is a global biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. They are a growing commercial business with a significant development pipeline. You will be responsible for overseeing operational aspects of all our clients regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget.
Manage document publishing for regulatory submissions from all areas of company, in support of global regulatory submissions which may include both paper and e-filings
Manage publishing activities for marketing applications in eCTD format; formatting, publishing, submitting, lifecycle activity, and archiving sequences
Supervise the management of electronic and/or paper-based regulatory records
Offer recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor)
Provide oversight for the selection and management of any outsourced publishing and records management vendors
Create and manage submission plans, in conjunction with Regulatory colleagues
Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities
Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team
Develop proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers in a secure and readily-accessible manner
Apply knowledge of electronic publishing requirements to ensure compliance with agency submission requirements and remain current with evolving standards for electronic submissions and inform other staff of these standards
Knowledge, Experience & Skills:
Eligibility to work in the EU
Bachelor’s degree with a minimum of 5 years experience in a Regulatory Operations role
Ability to work independently with moderate supervision
Ability to communicate and interact with a variety of personnel, including management and external vendors
Ability to direct operational staff to achieve submission publishing timelines successfully.
Excellent organizational skills, enough to multi-task and manage project timelines in an extremely fast-paced environment with changing priorities.
Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best practices.
Excellent knowledge of Word and Adobe Acrobat Pro required. Demonstrated expertise with submission publishing tools (eCTD building tools)
Hands-on experience with publishing, validating, and submitting a full marketing application in CTD format in the US/EU required.
If you are interested in discussing this role further, then please email your CV to email@example.com or call Amani on 01189 522 797 to arrange a confidential discussion.
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*.