Regulatory Affairs Manager at ISA Pharmaceuticals
Founded in 2004, ISA Pharmaceuticals is a privately held company based in Leiden, the Netherlands. With a dedicated team of 25 professionals, ISA focuses on the development of immunotherapies for the treatment of cancer and persistent viral infections. ISA’s immunotherapy platform is based on its proprietary SLP® (Synthetic Long Peptide) and AMPLIVANT® technologies. Various clinical trials up to completion of Phase II have demonstrated the safety, tolerability and clinical efficacy of SLP® immunotherapies. Because of our ongoing expansion we have the job opening for a Regulatory Affairs Manager.
You are accountable for the development and implementation of the regulatory strategy for one or more ISA products, so that these will be rapidly approved with the desired label. You work closely together with our internal drug development teams and our external advisors and become responsible for communication and interactions with FDA, EMA and other relevant authorities. You drive preparation of all regulatory applications. You closely monitor the regulatory landscape to keep abreast of new developments and effectively communicate them across the company.
You have a MSc degree (or comparable) in Medicine, Healthcare, Life Sciences or related field. You have a minimum of 6 years of relevant work experience in Clinical Development or CMC (of which at least 2 years focus on Regulatory Affairs) preferably in the field of biologicals, rare diseases and orphan designations. You have comprehensive knowledge of EU and US regulations and have proven ability to implement these into regulatory strategies. Within pharmaceutical or biotech setting, you have experience in driving MAA/NDA submissions.
We offer you a challenging position in a rapidly developing organization. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth.
The company culture of ISA is built on four important competences: high quality knowledge, a pragmatic & solution-oriented attitude, we are agile & resilient and appreciate collaboration & learning.
For further information on this job opening and related career opportunities, please contact Leon Hooftman at firstname.lastname@example.org or +31 71 3322310. We do not appreciate acquisition based on this advertisement.