Job type: Apprenticeship (12 months) as of September 2023
Hemerion Therapeutics is a clinical-stage healthcare company. The company is the result of over 10 years of academic and clinical research dedicated to providing innovative approaches to treating glioblastoma. Hemerion possesses a unique and innovative technology which has been evaluated in a first-in-man clinical trial for the treatment of this brain cancer.
Hemerion Therapeutics is looking for its future Regulatory Affairs Apprentice, who will contribute to all the department’s activities.
Hemerion Therapeutics: 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France.
Under the supervision of the Regulatory Affairs Manager, the apprentice takes part in the following activities:
- Regulatory intelligence on FDA & EU drug and medical device regulations.
- Creation and maintenance of tracking tables.
- Creation and maintenance of regulatory databases.
- Participate in the preparation of IND amendments or annual reports.
- Participate in defining the regulatory strategy in the USA and Europe.
- Writing working instructions.
- Participate in CMO follow-up.
Be accepted in an apprenticeship master’s program.
- Excellent verbal and written communication skills in French and English.
- Organized and able to meet deadlines.
- Skilled in planning and problem-solving techniques.
- Ability to work independently or with little supervision.
- Dynamic environment.
- Growing international company.
- Meal voucher.