Innovaderm Research Inc.
201 - 500 employés
💊 Pharmaceutique
🏥 Santé
💼 Conseil
Pharmaceuticals • Healthcare • Consulting
En tant qu'organisme de recherche sous contrat (CRO) spécialisé en dermatologie, nous offrons des conseils scientifiques, des résultats précis et la satisfaction du client. Notre offre de services unique combine des services de recherche sous contrat spécialisés, la connaissance des sites dermatologiques en Amérique du Nord et en Europe et les capacités étendues d'un grand site de recherche clinique.
Regulatory Affairs Specialist
Emploi pas sur LinkedIn
🕒 il y a 9 jours
🗣️🇺🇸🇬🇧 Anglais requis
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Innovaderm Research Inc.
201 - 500 employés
💊 Pharmaceutique
🏥 Santé
💼 Conseil
Pharmaceuticals • Healthcare • Consulting
En tant qu'organisme de recherche sous contrat (CRO) spécialisé en dermatologie, nous offrons des conseils scientifiques, des résultats précis et la satisfaction du client. Notre offre de services unique combine des services de recherche sous contrat spécialisés, la connaissance des sites dermatologiques en Amérique du Nord et en Europe et les capacités étendues d'un grand site de recherche clinique.
Description
• Prepare and submit Part I and/or Part II applications under the EU CTR and other applications created within or outside the company • Ensure regulatory documentation complies with applicable regulations and guidelines and contractual timelines are met • Provide leadership for assigned projects regarding regulatory activities leading to clinical-trial start-up • Prepare regulatory documents, CTA packages, and submissions in assigned countries • Coordinate regulatory timelines and deadlines for CTIS submissions, including oversight of EU, APAC, and North America submissions • Review regulatory documents and submissions prepared by subcontractors, partner CROs, and regulatory vendors before CTIS submission • Act as point of contact for sponsors, subcontractors, and project-management teams regarding study regulatory submissions • Prepare or review country-specific Patient Information Sheet/Informed Consent Form documents • Prepare or review study-specific regulatory-form templates • Manage translation requests with vendors • Provide regulatory support and advice on local requirements, EU submission strategy, and technical matters • Maintain knowledge of EU CTR and EU/EEA country-specific requirements • Maintain the regulatory intelligence database • Participate in kick-off meetings, audits, and other project-related meetings
🎯 Exigences
• Bachelor's degree (or equivalent) in a scientific discipline • Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Romania regulatory affairs is required • Experience in initial CTA is essential • Experience in a sponsor facing role is an asset • Previous experience with CTIS is an asset • Hands-on experience preparing, reviewing, and submitting regulatory documentations • Excellent knowledge of applicable EU regional / national country regulatory guidelines • Excellent knowledge of GCP and ICH standards • Fluency in English with excellent oral and written skills, required • Additional languages represent an asset • Excellent organization and communication skills, great attention to detail • Ability to organize own work, prioritize different assignments, and work under pressure • Versatile and comfortable in a multitasking environment • Respect established timelines, expectations, priorities, and objectives • Must be legally able to work in Romania
🏖️ Avantages
• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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