Regulatory Affairs Specialist

Kantoor: 
Sanofi
Referentie: 
1494665
Jobtype: 
Vast contract
Contract type: 
Bediende
Functieomschrijving: 

Position Title:
Regulatory affairs specialist - CMC (m/v)

Location:
Geel, Belgium

Department Description:
RSO

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)
- CMC Documentation management (CMC Author)
- Transversal activities
*Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs or with external partners for his/her site
*Contributes to site inspections and audits

Profiel: 

- 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

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