CMS Regulatory Officer - Sanofi - Vast contract (m/v)

Kantoor: 
Sanofi
Referentie: 
1397578
Jobtype: 
Vast contract
Contract type: 
Bediende
Functieomschrijving: 

Position Title 
CMC Regulatory Site Officer (RSO)

Location
Geel, Belgium

Department Description
QA Operations

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 and CPP for products manufactured on site
*Planning, tracking and reporting of regulatory activities/ approvals to the Head of QA Operations as well as to the different project managers

 

Profiel: 

Required Skills & Qualifications
- Master’s degree or equivalent in Pharmaceutical/ Biotech/ Life sciences
- 5 years’ experience and/or a degree in the field of Biotech industry
- Fluency in English (both oral and written communication) and a proficient level of Dutch
- 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

Aanbod: 

- You will get an open-ended contract at Sanofi with fringe benefits (meal vouchers, hospitalization insurance, group insurance, etc.)
- This position is in day shift with flexible hours
- A place in an international, changing and continuously growing environment