Regulatory Affairs Specialist
Support clients in the pharmaceutical industry by ensuring compliance with regulatory requirements.
* Key Responsibilities:
* Management of Marketing Authorisations (MA) Applications
* Management of variations and renewals applications to MAs
* Translations of regulatory procedures to be submitted to Authorities
* Development of readability tests/bridging reports
* Development of clinical/non-clinical reports
* Price and reimbursement applications
Our team works on various projects, including:
* Medical devices
* Cosmetics and Food Supplements
You will be responsible for:
* Techincal dossier writing
* Development of instructions for use and labeling
* Notification to competent authorities
Required Qualifications
To succeed in this role, you should have:
* A graduate degree in Pharmaceutical Sciences or other life sciences degree
* At least 2 years' experience in Regulatory Affairs
* Ease of expression and contact
* Proficiency in spoken and written English
We look forward to reviewing your application documents stating your earliest possible starting date.