Regulatory Affairs Manager M/W - France
Want to know company name or location? Company managed [?]
- Our company is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins.
- Our company's insulin formulation portfolio, featuring four clinical-stage products and one preclinical product, is among the largest and most differentiated in the industry.
Job presentation :
Within a multidisciplinary team of 130 people, you will actively participate in product development whilst working in close collaboration with other members of the Research and Development team.
The mission entails:
- Participating in the development and implementation of regulatory strategy for the company's projects,
- Identifying and defining the regulatory issues regarding CMC as well as nonclinical and clinical development,
- Interpreting the regulations and providing and informing teams of regulatory guidelines,
- Advising and assisting the different departments on regulatory aspects,
- Drafting and/or revising various regulatory documents such as IMPD, IND and IB,
- Managing the preparation of documents and answers to queries posed by health authorities,
- Identifying the relevant regulatory experts and supervising their services,
- Monitor regulatory changes and developments on an international level, and anticipate future regulatory trends.
- With a higher education in a relevant scientific field (postgraduate level), the ideal candidate would have at least 5 years' experience in a similar role within the pharmaceutical industry, as well as the following skills:
- An excellent command of English, both written and oral,
- Excellent interpersonal skills and a flair for teamwork.
- Passionate about Science and Innovation, you are motivated by an ambitious, competitive and promising environment.
- Our company promotes excellence in order to become a valuable partner to large pharmaceutical corporations specialized in the innovative treatment of chronic diseases.