Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Director EU and US - Genf, Genf - Teoxane SA
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vor 4 Wochen
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Regulatory Affairs Director
Vor 4 Tagen
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Regulatory Affairs Director EU and US
vor 1 Monat
Teoxane Laboratories were established in Geneva, Switzerland in 2003. They specialize in designing and manufacturing hyaluronic acid-based dermal fillers and dermocosmetics.
Job OverviewWe are looking for a highly skilled Regulatory Affairs professional to lead our team dedicated to Innovation & Life-cycle projects in the EU and US regions.
Key Responsibilities:- Develop a regulatory strategic roadmap aligned with business objectives and provide leadership for programs in the pre-market and post-market space.
- Provide strategic mentorship to ensure alignment of regulatory strategies with business objectives and implementation of strategic plans.
- Contribute to key strategic decisions impacting the development of global regulatory compliance processes and procedures.
- Maintain regulatory intelligence on new EU and US requirements and adapt the strategy accordingly.
- Collaborate with cross-functional teams to define regulatory pathways and develop regulatory strategies for submissions to Notified Body and FDA.
- Oversee the compilation of regulatory submission files for new products and product changes to achieve timely submissions/approvals.
- Respond to questions raised by Notified Body and FDA to ensure accurate and complete answers.
- Support life-cycle management activities, including change control regulatory impact assessment for EU and US regions.
- Ensure product compliance with EU and US regulations and standards.
- Lead preparatory activities, including briefing packages for interactions with FDA.
- Drive RA excellence by supporting the establishment, maintenance, and optimization of Regulatory Affairs processes and procedures.
- Minimum 10 years of experience in Regulatory Affairs.
- Expertise in EU and US regulations, particularly for high-risk medical devices.
- Proven track record of successfully managing teams and leading regulatory initiatives.
- Strong analytical skills and ability to make regulatory decisions.
- Excellent communication and negotiation skills.
- Demonstrated ability to work in a dynamic environment and handle multiple projects simultaneously.
Estimated salary range: $120,000 - $180,000 per annum, depending on qualifications and experience.
