We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Regulatory Affairs Specialist
- Prepare or contribute to the writing/review/preparation of regulatory dossiers and documents for medicinal and/or biotech products
- European dossier submission (CP, MRP/DCP, renewals)
- Variation procedures
- CTA submission
- PSUR/PSUSA submission
- Parallel import activities
- Packaging and labelling activities
- Preparation of agency meetings and regulatory designations (ODD, BTD…)
- PIP writing and submission
- Regulatory database updates
- Publishing activities
- Perform weekly regulatory surveillance
- 6th year of pharmacy studies. Master in regulatory affairs.
- Familiar with French and European regulatory requirements for medicinal products
- Distinctly strong service orientation
- Native French speaker and fluency in spoken and written English
- Ability to manage several projects with limited guidance
- Independent approach to work, flexibility and dedication
- Strong communication skills, social competency, integration capacity
- Strong sense of responsibility, organizational skills and intrinsic motivation
- Experience user of the MS Office package, Adobe Acrobat and database systems
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.