Aktuelle Jobs im Zusammenhang mit Regulatory Affairs CMC Manager - Genève - OM Pharma
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Senior Regulatory Affairs Officer
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Compliance Manager
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Compliance Manager
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Compliance Manager
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Senior Project Manager
vor 1 Woche
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R&D Project Manager
Vor 6 Tagen
Genève, Schweiz AXEPTA SA VollzeitWe are looking for an R&D Project Manager, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices.Join an innovator in the field of surgery, located in Geneva.R&D Project Manager - SpineResponsibilities:Contribute to the design and development of new productsCoordinate multiple projects simultaneouslyInteract with...
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R&D Project Manager
vor 2 Wochen
Genève, Schweiz AXEPTA SA VollzeitWe are looking for an R&D Project Manager, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices.Join an innovator in the field of surgery, located in Geneva.R&D Project Manager - SpineResponsibilities:Contribute to the design and development of new productsCoordinate multiple projects simultaneouslyInteract...
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R&d Project Manager
vor 2 Wochen
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R&D Project Manager
vor 2 Wochen
Genève, Schweiz AXEPTA SA VollzeitResponsibilities: Contribute to the design and development of new products Coordinate multiple projects simultaneously Interact with the different departments of the company, intervening in the different stages of the projects, from design to product launch Contribute to the maintenance of existing product lines Ensure compliance with applicable regulatory...
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Senior Project Manager
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Senior Project Manager
Vor 5 Tagen
1201 Genève, Schweiz AXEPTA SA VollzeitWe are recruiting on behalf of one of our prestigious clients for a Senior Project Manager specializing in medical devices. This role is a unique opportunity to join an innovative R&D team dedicated to advancing healthcare technologies, improving patient outcomes, and shaping the future of spinal arthroplasty. Senior Project Manager – Medical Device...
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Compliance Manager
vor 4 Wochen
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Compliance Manager
vor 1 Monat
Genève, Schweiz INOKS Capital VollzeitObjective Enforcing regulations in all aspects and levels of business as well as provide guidance on compliance matters regarding regulatory requirements for investors and investees. Direct contact with different regulatory authorities in particular FINMA, CSSF and CIMA. Your responsabilitiesKeep the company activities within the regulations and report any...
Regulatory Affairs CMC Manager
vor 3 Monaten
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.
For more information, visit the website: ompharma.com.
Regulatory Affairs CMC Manager - GenevaWe 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
