Location: Villeneuve d’Ascq & Boulogne-Billancourt - France
Requested experience: from 3 to 5 years
Hemerion Therapeutics is a clinical stage company specialized in Biotech. Hemerion results of over 10 years of leading academic and clinical researches on innovative approaches to treat Glioblastoma. These new technologies have been evaluated to treat brain cancer through a first-in-human clinical trial. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.
Today, to support its development, Hemerion looks for his/her regulatory affairs engineer.
To develop our market access and regulatory roadmap strategy, we are looking for a regulatory affairs and quality assurance Officer.
Position and responsibilities
Under the supervision of the CEO you will be in charge of structuring our Quality and Regulatory Affairs Department. As an EMA and FDA Regulatory Affairs officer, you will work closely with the R&D and industrialization teams. In collaboration with our partners and consultants, your missions are the following:
- To oversee and lead as officer of the function of regulatory affairs and develop the regulatory strategies for the accelerated approval of new our therapeutic approach,
- To manage and follow-up of the different pre-submission meetings with the health agencies,
- To draft, follow up and review premarket approval files for class III medical devices,
- To draft, follow up and review premarket approval files for investigative drugs,
- To maintain awareness of relevant global regulatory legislation and assess the impact of new technical standards and regulations and participate in the implementation of actions,
- To contribute to the production of our administrative documents and reports to be included in regulatory submissions,
- To set-up of ISO 13485 and 21 CFR 820 standards for our products.
- To contribute to our QMS set-up
- Good knowledge of regulatory procedures (FDA / EMA)
- Good understanding of regulatory tracking database software
- Good knowledge of ISO 13485 and 21 CFR 820 standards.
- Fluent in English and French for daily contacts with local and international partners
- Excellent organizational and interpersonal skills
- Ability to work well within a team
PhD, engineer or equivalent degree, you have at least 3 years of experience in regulatory affairs in regulatory affairs department within biotech/medTtech company. You must be experienced in preparing and following up preMarket authorization dossiers and have developed a good knowledge of both European American regulations.
- Dynamic environment with opportunities for advancement within the company
- International and growing company
- Flexible working environment
- Health insurance