Y-Axis Jobs Logo
Send us feedback
telephone  +91 7670 800 001
Log in Sign up Try Premium
Regulatory Site Officer (RSO) at Sanofi
Waterford, County Waterford, Ireland -
Full Time

Start Date

Immediate

Expiry Date

30 Nov, 25

Salary

0.0

Posted On

01 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

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.