CMC Specialist in Regulatory Affairs

INNOMEDICA IS A YOUNG NANOTECH COMPANY
with around 40 employees, several promising drugs in preclinical and clinical development and its own clean room production. The pipeline is based on a liposomal delivery system and includes, in particular, parenteral drug candidates applied in neurology (a new approach to treat Parkinson's disease) and oncology (chemotherapy).
For our Regulatory Affairs Team in Bern and Marly near Fribourg, we are looking for a
In this versatile position, you will support the development of InnoMedica's products in the areas of formulation/process development, production, and quality control. In doing so, you ensure that each development step and its related submission meet regulatory requirements to be approved by the authorities.
Your job profile includes:
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Identification of product-specific regulatory requirements, development of regulatory strategies, and clarification of open questions in collaboration with the authorities
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Participation in interdisciplinary working groups and contribution of regulatory expertise in the area of CMC (Chemistry, Manufacturing, and Control)
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Management and updating of regulatory quality documentation (PQD/IMPD-Q) for products
As prerequisites for this position, you hold a degree in Pharmaceutical Sciences, (Bio)Chemistry, or a related field, preferably with a PhD. You have basic knowledge of cGMP, experience in industrial manufacturing or analytics, and familiarity with Regulatory Affairs. You possess excellent writing skills in both German and English and are able to present complex issues in a clear and audience-appropriate way. As a communicative team player, you value broad interdisciplinary collaboration. Thanks to your solution-oriented approach, you contribute your perspective constructively while considering the concerns of other teams. You work independently, are proactive, and enjoy taking on technical responsibility within projects.
Interested candidates are kindly requested to send their application documents in PDF format to Ms Noëlle Haas, who can also be contacted for additional information by phone (058 521 35 01) or e-mail (
Write an email (https://www.jobs.ch/external/email-application/F%2FbMahsMUNUqsByDBes9SjdIAiq2aPvARIGkzAtiUrQ%3D/f756ee7c-c029-445b-8aaf-aa02baf59f87)
).
InnoMedica
Frau Noëlle Haas
HR Specialist
058 521 35 01