Auf einen Blick
- Aufgaben: Entwickle globale Strategien für Regulatory Affairs CMC in der klinischen Entwicklung.
- Unternehmen: Innovatives biopharmazeutisches Unternehmen in der Nordwestschweiz.
- Vorteile: Einflussreiche Rolle mit direkter Beteiligung an globalen Entwicklungsaktivitäten.
- Weitere Informationen: Möglichkeiten zur Zusammenarbeit mit externen Partnern und bedeutende Karrierechancen.
- Warum dieser Job: Gestalte die Zukunft innovativer Therapien und arbeite mit führenden Experten zusammen.
- Qualifikationen: Erfahrung in Regulatory Affairs CMC und starke Kommunikationsfähigkeiten.
Das prognostizierte Gehalt liegt zwischen 85500 - 104500 € pro Jahr.
Innovative Biopharmaceutical Company | Northwestern Switzerland Shape the Global Regulatory Strategy for Innovative Small Molecule Therapies Our client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development.
As the organization prepares for pivotal development milestones and future marketing applications, we are looking for an experienced Regulatory Affairs CMC professional who combines strategic thinking with hands‑on regulatory expertise across clinical development and registration.
This position offers the opportunity to become a key member of the Regulatory organization and to play an important role in future regulatory leadership.
Your Responsibilities Develop and execute global Regulatory Affairs CMC strategies across clinical development and registration programs.
Lead and coordinate CMC regulatory activities from clinical development through marketing application.
Prepare, review and drive high-quality Module 3 documentation for global regulatory submissions.
Support and coordinate IND, IMPD, CTA, NDA and MAA submissions.
Represent Regulatory Affairs CMC in multidisciplinary project teams.
Provide strategic regulatory guidance throughout product development, technical changes and lifecycle planning.
Prepare and support interactions with regulatory agencies including FDA, EMA and other Health Authorities.
Collaborate closely with CMC Development, Pharmaceutical Development, Manufacturing, Analytical Development, Quality and external development partners.
Evaluate regulatory risks and contribute to overall development strategy.
Your Profile Degree in Pharmacy, Chemistry or another Life Science discipline.
Several years of experience in Regulatory Affairs CMC within biotech or pharmaceutical development.
Proven experience supporting clinical development programs through late‑stage development and registration.
Demonstrated experience with IND, IMPD, CTA, NDA and/or MAA submissions.
Strong expertise in CTD Module 3.
Experience interacting directly with regulatory agencies such as FDA and EMA.
Solid background in small molecule development.
Excellent communication skills with the ability to influence multidisciplinary project teams.
Preferred Experience Experience supporting first marketing applications.
Experience in innovative biotech environments.
Experience working with outsourced manufacturing organizations and external development partners.
Scientific background combined with pragmatic regulatory thinking.
Previous exposure to global development programs from Phase I through registration.
What You Can Expect A highly visible strategic role within an innovative biotechnology company.
Direct involvement in global development and registration activities.
Close collaboration with experienced scientific and regulatory leaders.
Broad responsibility with significant influence on development strategy. #J-18808-Ljbffr
Associate Director / Senior Regulatory Affairs CMC Arbeitgeber: gloor & lang Pharma and Biotech Recruiting
Als operativer Einkäufer im Bereich Electronics in einem innovativen Industrieunternehmen erwartet dich eine verantwortungsvolle Aufgabe in einem technologisch geprägten Umfeld. Du profitierst von modernen Arbeitsbedingungen, einer offenen Kommunikationskultur und der Möglichkeit, aktiv an Prozessoptimierungen mitzuwirken. Zudem bieten wir dir langfristige Perspektiven und enge Zusammenarbeit mit verschiedenen Fachbereichen sowie internationalen Lieferanten, was deine persönliche und berufliche Entwicklung fördert.
Kontaktdaten:
gloor & lang Pharma and Biotech Recruiting Recruiting-Team
