CMC pre-approval regulatory manager

We are recruiting a CMC Pre-approval Regulatory Manager at our headquarters and biotech production site in Geneva. Reporting to the Regulatory Affairs CMC Team Lead, your mission is to provide regulatory expertise on CMC technical activities for initial registration in the context of biological development projects, in order to ensure regulatory compliance of the products to be registered.

Your main responsibilities are as follows:

Develop, plan and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with other regulatory sub-functions and other functions such as quality, clinicals as example
Plan and prepare the CMC regulatory dossiers and manage responses to Health Authority Questions according to current internal procedures, applicable regulations/guidelines for clinical phases and initial registration, in collaboration with technical Subject Matter Experts and other Regulatory sub-teams.
Perform regulatory assessment for change controls related to CMC topics in the context of development and manage submission of CMC amendments for clinical phases accordingly
Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across a multifunctional team.
Provide regulatory leadership and guide/influence by providing your regulatory expertise on CMC topics
Contribute to an entrepreneurial environment to achieve a robust outcome on project decisions, constructively challenge teams to reach the best solutions to issues
Develop and share CMC regulatory expertise
To carry out this mission, we are looking for a person with the following profile:

Academic degree in the fields of Biological/biotechnology sciences or a similar educational background
At least 5 years of experience in CMC pre-approval regulatory affairs or drug substance/drug product development with regulatory expertise, experience in registration of biological products
Pharmaceutical industry experience in CMC technical drug development is desirable
Experience in authoring CMC technical dossiers for EU and US territories would be appreciated
Ideally, experience in the development of products administered by the nasal route, products issued from fermentation process, combination products and medical devices (class I)
Fluent in English with strong oral skills in French
You describe yourself as a solution-oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach, and the ability to deal with tight deadlines. You also demonstrate strong adaptability, communication and negotiation skills, and you like to interact with various stakeholders.

Are you interested in this opportunity? Apply now and join OM Pharma.