Regulatory Affairs Market Manager F/m
il y a 2 semaines
A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network. Come and join a family-owned global company with a long-term vision, and a human-centered culture. **What will be your activites at bioMérieux?** The Regulatory Affairs Market team is looking for a Regulatory Affairs Manager for supporting all business regions (EME-AFRICA-ASPAC-LATAM-NORAM) in the frame of new RA organization. The RA Market Dev & Support team composed of 9 people based in France and in United States. The activities performed by the team are: - Daily contacts with the local regulatory teams (subsidiaries and distributors) in order to register/renew products. - Regulatory watch in order to identify requirements and develop the adequate RA strategies - Answer to question from authorities with support from other departments Reporting to the RA Market Director, your main responsibilities will be: - Organizing activity within the team considering Region business priorities. Monitor progress, identify quickly when prioritization required, escalade success and difficulties when relevant - Provide expertise to the team to assist the activities and during audits/ inspection - Ensuring that internal tools are updated (activity data capture and RA watch impacts) - Building strong partnership with subsidiaries, distributors and counterparts - Set in place/adapt process and tools to ensure that Regulatory activities are performed efficiently by the team. Size opportunity for process improvements - Develop robust RA watch process in order to adapt regulatory strategies. - Support transversal project within Regulatory Affairs team **Who are you ?** With a scientific background (master degree) and specialized in regulatory affairs, you have at least 5 years of professional experience in regulatory affairs, either in medical devices or in a "Region" position. You have a previous experience in team management and your leadership is recognized. You have good communication skills, you know how to interact in an international environment and your English level allows you to influence, challenge and negotiate. Speaking Spanish would be an advantage. Finally your strong coordination and prioritization capacities along with your solution oriented mindset will be success factors.
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Regulatory Affairs Associate
il y a 7 jours
Lyon, Auvergne-Rhône-Alpes, France Resourcing Life-Science Temps pleinResponsibilitiesConduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.Manage annual registrations, license renewals, and ongoing regulatory notifications.Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.Coordinate the...
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Chemical Regulatory Affairs Manager – LyonNonStop Consulting
il y a 2 semaines
Lyon, France NonStop Consulting Temps pleinChemical Regulatory Manager – Lyon Our client, a leading global provider of market expansion services with a strong presence in the chemical industry, is seeking a skilled and dedicated Chemical Regulatory Manager. This pivotal role will be based at their offices on the periphery of Lyon, with a flexible hybrid model allowing for 2 days of home working per...
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Senior Regulatory Affairs Project Manager
il y a 5 heures
Lyon, France Nemera Temps plein**Company Description** With sales of €600m and 3,000 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has...
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Regulatory Affairs Manager M CDI H/F
il y a 2 jours
Lyon, France Nemera Temps pleinWe are currently looking for passionate people ready to make a difference in the following open position: Regulatory Affairs Manager F/M/X, based in Lyon (7e). Within Nemera's headquarters, you will lead the Regulatory & Compliance design projects of drug delivery devices for one of our strategic products BU. You will report to the Quality and Regulatory...
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Regulatory Affairs
il y a 2 jours
Lyon, Auvergne-Rhône-Alpes, France Alan Temps pleinWho we areYou. Better. With Alan.Alan's vision is to make prevention the new norm of care for all.Our mission is to help people live in good health to 100 while helping employers feel proud, turning health benefits from a cost centre into their most valuable investment.We're building avertically integrated health partnerthat seamlessly unites insurance and...
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Regulatory Affairs Manager M/F/X
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Nemera Temps pleinCompany DescriptionWith sales of €500m and 2,800 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has...
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Regulatory Affairs Manager M/F/X
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Nemera Temps pleinCompany Description With sales of €500m and 2,800 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has...
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Business Develoment Manager
il y a 2 semaines
Lyon, France Staphyt Temps plein**About us**: We strengthen science together! Present in Europe, North Africa, South America, STAPHYT brings together more than 700 employees, of different nationalities and cultures. Rich in multiple profiles, a wide range of expertise is expressed in the Group, through our areas of activity which are agronomic experimentation, regulatory advice and...
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Regional Regulatory Manager
il y a 2 jours
Lyon, France FMC AGRO POLSKA SP. Z O.O. Temps plein**About us** We, FMC Agricultural Solutions, provide innovative crop protection solutions to growers around the world. Thanks to the commitment of our 5,200 employees, we are one of the six largest crop protection manufacturers in the world. For any FMC office located in EU we are looking for a **Regional Regulatory Manager (m/ f/ d)** As a Regional...
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Regulatory and Compliance Project Manager
il y a 2 semaines
Lyon, France Nemera Temps pleinWe are currently seeking a** Regulatory and Compliance Project Manager **with combination products experience to join our growing team and independently lead an end-to-end submission process. The role will require hands-on experience in Technical Files, IND, NDA, and BLA submissions specific to the US and EU markets. Reporting to the Regulatory and...
