Regulatory Site Officer (RSO)
- Location Waterford
- 23-month FTC
About Waterford
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.
About the job
The Regulatory Affairs Department in Waterford is responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance.
Our team is an energetic and close-knit, helping each other where we can.
Main responsibilities:
- Maintenance of, and variations to, CMC Dossier for assigned products.
- Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs).
- Assess the regulatory impact of proposed changes by site for assigned products.
- Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate.
- Second RSO review for submission documentation.
- Track all site regulatory activities in real time within the site planning tracking tools.
- Monitor submission/approval status and track updates for assigned products.
- Participate in regulatory inspections/audits.
- Initial BLA/MAA authoring/coordination, as appropriate.
- Product Registration Renewals.
- Annual Reports e.g. US, Canada, Brazil.
- Periodic Quality Reviews (PQR).
- Contribute in project teams and provide regulatory guidance/ support.
- Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites.
- Dossier Compliance.
- Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalisations and notarisation requests.
- Preparation of Site Master File (SMF).
- Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification.
- Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR).
- Distribution of approval notification to site.
- Document review (Geode+/Veeva Vault).
- Ensure Quality tasks are completed in timely manner.
About you:
- Preferably 2 years+ in a similar role.
- Problem Solving, effective communication, critical thinking and time management.
- Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Heal Authorities and working through corporate structure is desirable.
- Degree in Science, Pharmacy or related discipline is essential.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
