Regulatory Affairs Officer - 712

In the context of our growing activities, we are looking for a Regulatory Affairs Officer to join our teams in Germany.

Responsibilities

Contribute to the production of client administrative documents to be included in regulatory submissions
Compile regulatory dossiers in accordance with national requirements.
Document and track regulatory submissions and regulatory authority approval inside document management systems.
Provide regulatory support to clients and associate companies
Liaise with sponsor head-office and affiliate departments on regulatory issues.
Provide review of packaging texts.
Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

Bachelor’s degree or more in a Life Sciences related field.
At least 1 year of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Previous experience in a consulting company would be a plus

Hard/Technical skills:

Native German mandatory along with fluent English
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel

Soft skills: