Job Description
Are you a strategic leader in pharmaceutical regulatory affairs seeking to drive innovation at a world-class biotechnology firm? Novara BioSciences is expanding our Regulatory Affairs team in Basel and is looking for a Senior Regulatory Affairs Manager to oversee our global compliance and submission strategies.
As a pivotal member of our Global Regulatory Team, you will be responsible for the lifecycle management of our drug candidates, ensuring seamless interactions with EMA, FDA, and other health authorities. You will shape the regulatory strategy that brings life-saving therapies to patients worldwide.
Why Novara BioSciences?
- Work with cutting-edge biologics and small molecule therapies.
- Comprehensive benefits package including Swiss pension schemes and health insurance.
- Collaborative culture fostering professional growth and scientific excellence.
Apply today to join a team dedicated to transforming patient outcomes through regulatory excellence.
Responsibilities
- Lead the preparation, review, and submission of regulatory dossiers for New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs), and supplements.
- Manage the regulatory lifecycle, including CMC (Chemistry, Manufacturing, and Controls) documentation and lifecycle management.
- Liaise effectively with Health Authorities and regulatory experts to resolve queries and ensure compliance.
- Develop and maintain regulatory strategies aligned with global business objectives and market opportunities.
- Oversee the management of regulatory vendors and external consultants.
- Ensure strict adherence to GCP, GMP, and ICH guidelines across all submission materials.
Qualifications
- Master’s degree in Pharmacy, Life Sciences, or a related field (PharmD, PhD preferred).
- Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Proven track record of successful submissions to EMA and/or FDA.
- Deep understanding of CMC, pharmacology, and clinical development processes.
- Fluency in English and German (written and verbal) is highly desirable.
- Strong leadership skills with the ability to mentor junior team members.
- Excellent organizational and project management abilities.