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Regulatory Affairs Manager (based in Basel)

CAREER OPPORTUNITY

Regulatory Affairs Manager (based in Basel)

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer. The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune is currently seeking a Regulatory Affairs Manager within Clinical Development based in Basel. The selected candidate will manage and implement regulatory strategies and will work closely with external regulatory partners.

Description of activities:

• Ensures that all aspects of regulatory affairs are properly planned and executed according to regulatory requirements.


• Keep up to date with the latest regulatory requirements with the focus on Novimmune’s regulatory strategy


• Manages the end-to-end labelling process, including the product label information development, review and approval of labels.


• Maintains the assigned Regulatory Databases according to internal guidelines


• Ensures post-marketing compliance including compliance with safety and annual reporting


• Coordinates submission files according to the defined timelines (renewals, variations, responses to Health Authorities questions…) and prepares and reviews technical documentation as needed by the Health Authorities


• Liaises with QA in case of safety alerts, manages corrective actions plan when necessary.


• Cooperates with internal stakeholders such as Global Drug Safety, QA and other departments to ensure regulatory compliance.

Education, experience and competences:

• Degree in Life Sciences, Pharmaceutical Sciences or Medical is required


• At least 5 years of experience in Regulatory Affairs are required


• Ability to perform comprehensive gap assessments and build effective regulatory strategies (good knowledge and appropriate interpretation of guidelines, directives etc…


• Self-assertion, creative and solution-oriented work approach


• Accuracy, flexibility, open minded, team spirit, organised, autonomous


• Strategic thinking and acting, entrepreneurship skills


• Excellent communication and negotiation skills at all levels, diplomacy and respectful behavior


• Good command of French and English both in written and oral conversation is required

If your profile matches the above description, please send us your CV and motivation letter under the reference RAM-2019 to the following email address: hr-recruitment@novimmune.com