Regulatory Site Officer

Regulatory Site Officer

Sanofi

Geel, Belgium

Job overview

He/She:

  • Supports regulatory compliance for marketed products by means of a correct and timely handling of all regulatory activities on his/her site(s)
  • Manages regulatory activities linked to change controls and deviations for his/her site(s) including updating of CMC files
  • Supports product licenses maintenance and site registrations
  • Ensures the role of regulatory expert for all regulatory topics and projects on his/her site(s)

Responsibilities

Regulatory Compliance

  • Ensures that the CMC dossier is in line with manufacturing and control procedures on site and with the corresponding dossiers approved by Health Authorities

Change Control and Deviations (RSO)

  • Provides regulatory expertise to site projects
  • Pre-assesses Change Control and assesses Deviation activities on their regulatory impact on his/her site(s) and manages their regulatory implications

CMC Documentation management (CMC Author)

  • Manages, coordinates and ensures the writing of CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission including answers to questions from Health Authorities
  • Supports product licenses maintenance and site registrations: supports Marketing Authorizations worldwide (renewals, site registrations and transfers…) by ensuring the writing of the corresponding CMC documents/dossiers and collecting GMP related documents from the site.

Transversal activities

  • Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs or with external partners for his/her site
  • Implements the appropriate company tools to manage all his/her activities
  • Contributes to site inspections and audits
  • Supports all regulatory topics and projects on the site by providing regulatory expertise and evaluations
  • Reviews and signs-off site documents with possible regulatory impact such as (General Site Related SOPs, Specification Sheets (buffers, media, intermediates, API), Stability Protocols and Reports ((buffers, media, intermediates, API), Validation and Qualification Protocols and Reports, Analytical and Process Comparability Plans and Reports, Site Master File, Annual Quality Review
  • Maintains GMP Manufacturing License and interacts with FAMHP on GMP Certificates in view of production activities
  • Planning, tracking and reporting of regulatory activities/ approvals to the Regulatory Site manager as well as to the different project managers

Required Skills & Qualifications

  • Master’s degree or equivalent in Pharmaceutical/Biotech/Life sciences
  • 3-5 years’ experience and/or a degree in the field of Biotech industry
  • Fluency in English (both oral and written communication)
  • Knowledge/Experience in Chemistry Manufacturing and Control (CMC)
  • Knowledge/Experience in CMC writing; writing of technical documents and reports
  • Knowledge/Experience in Regulatory registration and maintenance, GMP and health-related regulations
  • Project management skills
  • Cooperate transversally and negotiate efficiently
  • Strive for results and make decisions
  • Commit to customers
  • Think strategically and be able to asses risks/ alerts in their field
  • Develop people and lead and motivate teams (direct and transversal)

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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