Site Regulatory Officer

About the Role

Adecco is seeking a dedicated Site Regulatory Officer to join a team in Waterford, County Waterford, Ireland. This full-time, onsite position focuses on managing and maintaining regulatory documentation and compliance for assigned products. The role involves close collaboration with internal departments and external health authorities to ensure adherence to all regulatory requirements.

Main Responsibilities

• Manage and update the CMC Dossier for designated products.
• Coordinate responses to regulatory requests and support the GRA in addressing information requests from Health Authorities, including deficiency letters.
• Evaluate the regulatory implications of proposed changes within the site for assigned products.
• Review and approve critical quality documentation such as batch records, specifications, plans, protocols, technical reports, SOPs, deviation assessments, and failure investigations.
• Conduct second-level reviews for submission documentation.
• Maintain real-time tracking of all site regulatory activities using designated planning tools.
• Monitor the status of submissions and approvals, and track relevant updates for assigned products.
• Participate actively in regulatory inspections and audits.
• Contribute to the initial authoring and coordination of BLA/MAA submissions.
• Manage product registration renewals and prepare annual reports for various regions (e.g., US, Canada, Brazil).
• Oversee Periodic Quality Reviews (PQR).
• Provide regulatory guidance and support within project teams.
• Lead product-related meetings, including site core meetings, meetings with GRA, and discussions with RSO counterparts at sister sites.

Compliance Related Tasks

• Ensure regulatory and dossier compliance.
• Create and maintain Overarching and Batch specific MARs/MCAs.
• Manage legalisation and notarisation requests.
• Prepare and maintain the Site Master File (SMF).
• Oversee the maintenance of local site accreditations, such as investigational manufacturing licenses (IMP), manufacturing licenses, and GMP certifications.
• Handle site registrations and renewals, including Foreign Manufacturing Registration (FMR).
• Distribute approval notifications to the site.
• Conduct document reviews using Veeva Vault.
• Ensure timely completion of all quality-related tasks.

About You

The ideal candidate will possess a degree in Science, Pharmacy, or a related discipline. A minimum of two years of relevant experience is preferred. Strong problem-solving, critical thinking, effective communication, and time management skills are essential. Experience in Regulatory Affairs, Manufacturing, and/or Quality Operations, coupled with experience interacting with Health Authorities and navigating corporate structures, is highly desirable. Fluency in English is required.

Additional Information

Adecco Ireland is acting as an Employment Business in relation to this vacancy.