Regulatory Affairs CMC Manager
vor 1 Monat
We are recruiting a Regulatory Affairs CMC Manager at our headquarters and biotech production site in Geneva. Reporting to the Head of CMC, your mission is to provide expertise on regulatory CMC activities for initial registration in the context of development projects and lifecycle activities, while ensuring regulatory compliance of the registered products to the legal requirements, regulatory standards of the markets and internal standards/procedures.
Your main responsibilities are as follows:
- Ensure the preparation of the CMC part of the regulatory dossier according to current internal procedures and current applicable regulations/guidelines for clinical phase, initial registration and lifecycle activities.
- Support the submission of CMC amendments for clinical phases in collaboration with other Regulatory Affairs sub-teams.
- For registered products in European countries and Switzerland, define regulatory strategy and lead the submission in collaboration with other Regulatory Affairs sub-teams for CMC topics.
- For registered products in other countries, support the submission with other Regulatory Affairs sub-teams for CMC topics.
- Manage Health Authority Questions and Post Approval Commitment in collaboration with subject Matter Experts and other Regulatory Affairs sub-teams.
- Act as the contact point for technical teams and provide regulatory expertise in the context of projects under your responsibility.
- Perform regulatory assessment for change controls related to CMC topics and complete regulatory actions related.
To carry out this mission, we are looking for a person with the following profile:
- Academic degree in the fields of natural sciences, medicine or similar educational background.
- At least 5 years of experience in Regulatory Affairs with proven expertise in CMC biotechnology and initial registration of biological products.
- Experience in CMC writing of clinical phase dossiers for EU and US territories.
- Ideally, experience in development of products administered by nasal route, products issued from fermentation process, combination products and medical devices (class I).
- Fluent in English with good 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 by 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
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