Regulatory Affairs Specialist

Job not on LinkedIn

🔥 20 hours ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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