Our client is an innovative Irish pharmaceutical business focused on rare and genetic diseases. Due to a recent acquisition and continued expansion, they are seeking an experienced Senior Regulatory Affairs Operations Specialist to join the team in Dublin City Centre.
You will be responsible for overseeing operational aspects of all regulatory submissions and overseeing the effective and appropriate management of all regulatory documentation. Other duties and responsibilities will include:
- Managing document publishing for regulatory submissions from all areas of the company, in support of global regulatory submissions which may include both paper and e-filings
- Managing publishing activities for marketing applications in eCTD format; formatting, publishing, submitting, lifecycle activity, and archiving sequences
- Overseeing the management of electronic and/or paper-based regulatory records
- Providing recommendations on resource needs for regulatory operations and records management activities
- Creating and managing submission plans, in conjunction with Regulatory colleagues
You will have skills and experience in the following:
- Bachelors degree and 5+ years' experience in a Regulatory Operations role
- 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
- Expert knowledge regarding global regulatory submission standards, software validation concepts, and publishing best practices
- Excellent knowledge of Word and Adobe Acrobat Pro required
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.