Regulatory Affairs Director
vor 3 Wochen
Teoxane Laboratories is a pioneering company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Our commitment to innovation, quality, and patient care has led us to establish a global presence.
Job OverviewWe are seeking an experienced Regulatory Affairs professional to join our team as Regulatory Affairs Director - EU & US Regions. This key role will lead our regulatory strategy and ensure compliance with EU & US regulations for our innovative products.
Job Description- Regulatory Strategic Roadmap: Develop and implement a comprehensive regulatory strategic roadmap aligned with business objectives, providing regulatory leadership for programs in pre-market and post-market spaces.
- Strategic Mentorship: Provide guidance and mentorship to ensure alignment of regulatory strategies with business objectives and effective implementation of strategic plans.
- Regulatory Intelligence: Monitor new EU & US requirements through the regulatory intelligence process, adapting our strategy accordingly.
- New Product Development: Contribute to regulatory strategy in the framework of new product development, defining regulatory pathways and developing submission files for Notified Body and FDA approval.
- Life-Cycle Management: Oversee life-cycle management activities, including change control regulatory impact assessments, to ensure timely submissions and approvals.
- Expertise: Possess a deep understanding of EU & US regulations, particularly in high-risk medical devices, and have experience in regulatory affairs leadership.
- Leadership Experience: Proven track record of leading cross-functional teams and managing multiple projects simultaneously.
- Communication Skills: Excellent communication skills, with the ability to effectively interact with regulators, internal stakeholders, and external partners.
- Education: A relevant diploma and minimum 10 years of experience in regulatory affairs.
The estimated salary for this position is approximately $140,000 - $160,000 per annum, depending on qualifications and experience. We offer a comprehensive benefits package, including health insurance, retirement planning, and opportunities for professional growth and development.
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Regulatory Affairs Director EU
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Genf, Genf, Schweiz Teoxane SA VollzeitRegulatory Affairs Director EU & US RegionsTeoxane Laboratories is seeking a highly experienced Regulatory Affairs Director to lead our EU & US regulatory team. As a key member of our innovation and life-cycle projects, you will provide strategic expertise and leadership to our business partners and stakeholders.Develop and implement regulatory strategies to...
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Genf, Genf, Schweiz Teoxane SA VollzeitTeoxane SA, a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking an experienced Regulatory Affairs Director to oversee the management of its EU & US team. The successful candidate will provide leadership and expertise to business partners and stakeholders across multiple functions, including R&D, Clinical, Quality,...
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