Regulatory Project Manager
il y a 4 jours
About Nemera
Nemera is a leading global manufacturer of complex drug delivery systems for the pharmaceutical industry. With sales of €600m and 3000 employees worldwide, we offer a broad product portfolio that includes inhalation devices, injection devices, nasal and dermal pumps, and ophthalmic delivery devices.
We have built strong relationships with leading global pharmaceutical companies by providing high-quality development, industrialization, and manufacturing services. Our manufacturing sites are located in the US, France, Germany, Brazil, and Poland, with our headquarters and Innovation Center for early device design and development located in Lyon.
About the Role
You will work closely with our development team to define regulatory strategy, support quality management plans, and develop and improve processes. You will prepare, verify, and submit regulatory documents, collect normative information, and provide training to project, plant, marketing, and sales teams.
Key Responsibilities
- Develop and implement regulatory strategies for complex drug delivery systems
- Support quality management plans and develop and improve processes
- Prepare, verify, and submit regulatory documents
- Collect and analyze normative information
- Provide training to project, plant, marketing, and sales teams
Requirements
- Background in pharmaceutical or biomedical industry
- Experience in quality management systems and GMP
- Knowledge of medical device design with products such as syringes, autoinjectors, and pumps
- Good English speaking and writing skills
- International committee experience
What We Offer
- Opportunity to work in a multicultural and interdisciplinary environment
- Chance to grow a business and develop new skills
- Flexible working arrangements, including the possibility of working from home 2 days per week
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