Start Date
- November 1st
Location
- Dublin, Ireland
Duration
- 12-Month Contract
Schedule
- hybrid/ 2 days on site 3 days remote
Job Summary
- Our client is seeking an experienced Regulatory Operations Contractor for a 12-month contract. This role will be pivotal in managing regulatory ops group supporting a small team for regenerative medicine products, drafting and reviewing SOPs and ensuring the accuracy and compliance of regulatory artwork.
Responsibilities
- Draft, review, and update Standard Operating Procedures (SOPs) related to regulatory operations
- Collaborate with cross-functional teams to ensure SOPs reflect current regulatory requirements and operational practices.
- Maintain version control and documentation for all SOPs, ensuring they are up to date
- Track submission timelines and ensure that deadlines are met, communicating any potential risks
- Review product artwork and labeling (including packaging, inserts, and promotional materials)
- Maintain regulatory submission archives
- Regulatory Compliance and Documentation
- Review and ensure accuracy of all submission-ready documents
- Identify areas for improving submission processes, SOP management, and artwork review workflows.
Qualifications
- Bachelor’s degree in Life Sciences
- 5+ years of experience in regulatory operations
- Strong experience with SOP writing and review
- Experience reviewing regulatory artwork, labeling, and product packaging to ensure compliance with global standards.
- Proficiency in eCTD publishing software and knowledge of global regulatory submission requirements
- Familiarity with RIMS
- Irish regulatory affairs experience
Hybrid in Dublin, Ireland: Regulatory Ops Contractor (235739) #LI-Hybrid