Job type: Internship (6 months)
Company
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.
Description
Hemerion Therapeutics is looking for its future Regulatory Affairs Intern, who will contribute to all the department’s activities.
Location
Hemerion Therapeutics: 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France.
Responsibilities
Under the supervision of the Regulatory Affairs Manager, the intern 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.
Qualifications
Student in a regulatory affairs master’s program.
Competence
- 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.
Job benefits
- Dynamic environment.
- Growing international company.
- Meal voucher.