Location: Villeneuve d’Ascq (59) & Boulogne-Billancourt (92) – France
Requested experience: at least 4 years
Hemerion Therapeutics is a health tech company at a clinical level. 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 our development, we look for our future regulatory affairs PharmD.
To strengthen our clinical development and regulatory roadmap strategy, we are looking for our future PharmD Regulatory Affairs Associate with previous experiences in clinical development phases (Phase I-III).
Position and responsibilities
Under the supervision of the CEO you will oversee drug regulatory affairs alongside the different clinical development phases. In collaboration with our partners and consultants, your missions are the following:
- To oversee and develop all pre-market regulatory strategies regarding the drug development to accelerate the approval of our new therapeutic approach
- To outsource and manage partnerships with manufacturers, CDMO/CMO
- To draft, follow up and review premarket approval files for investigational new drugs
- To contribute to the design of upcoming clinical trials and define the best endpoints to support the drug development
- To manage and follow-up of the different pre-submission meetings with the health agencies
- To design and oversee the industrial processes involved in our drug development strategy
- 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 our quality management system set-up
- To contribute to the production of our administrative documents and reports to be included in regulatory submissions
- Good knowledge of regulatory procedures (FDA / EMA)
- Good knowledge of CMC, IND, IMPD
- Good understanding of clinical trials during premarket approval
- Fluent in English and French for daily contacts with local and international partners
- Excellent organizational and interpersonal skills
- Ability to work well in autonomy and within a team
PharmD graduate, you have at least 4 years of experience in regulatory affairs of drug specialties within a biotech company. Experience in a startup company would be appreciated. You must have experience in the preparation and follow-up of pre-marketing authorization dossiers and have developed a good knowledge of European and American regulations would be appreciated.
- Dynamic environment with opportunities for advancement within the company
- International and growing company
- Flexible working environment