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Regulatory Project Director
Il y a 2 mois
Nemera is a leading global manufacturer of complex drug delivery systems for the pharmaceutical industry, offering a broad product portfolio that includes inhalation devices, injection devices, nasal and dermal pumps, and ophthalmic delivery devices.
Job DescriptionWe are seeking a highly skilled Regulatory Project Director to join our team. As a key member of our development team, you will work closely with us to define regulatory strategies, support quality management plans, and develop and implement QMS processes.
Key Responsibilities:
- Prepare, verify, and submit regulatory documents to authorities, notified bodies, and customers.
- Collect and summarize regulatory and normative requirements.
- Provide training to project, plant, marketing, and sales teams on regulatory and normative requirements.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Requirements:
- Background in pharmaceutical or biomedical industry with experience in quality management systems and GMP.
- Knowledge of medical device design with products such as syringes, autoinjectors, and pumps.
- Excellent English speaking and writing skills.
- International committee experience with technical discussions.
We offer a dynamic and multicultural work environment, with opportunities for professional growth and development. If you are passionate about growing a business and have a strong background in regulatory affairs, we encourage you to apply.
