Country Regulatory Specialist, Clinical Research

🔥 7 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform assigned activities related to country regulatory operations under supervision • Provide delivery and expertise in country ethics and regulatory submissions from startup through project end • Serve as the main country-level contact with Regulatory Authorities and Central/Regional Ethics Committees under project leadership direction • Maintain regulatory country intelligence in regulatory intelligence systems • Interact with customers regarding Regulatory Authority and local regulatory requirements • Consult on pre-award regulatory submission strategy • Provide country-level regulatory subject matter expertise for business development presentations and site selection • Maintain intelligence on country-specific startup timelines and provide strategic recommendations • Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks • Prepare and submit Central EC, Local EC, Regulatory Authority, hospital, amendment, periodic notification, safety notification, and other local submissions • Interact with Regulatory Authorities and Ethics Committees, coordinate query responses, and identify solutions to issues • Serve as country-level regulatory SME throughout assigned projects • Submit relevant documents to the Trial Master File in compliance with SOPs and customer requirements • Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change • Develop or support local country regulation training materials • Support Procurement in managing Ethics/IRB vendors when required • Ensure continuous quality improvement for country-level submissions and communications • Comply with SOPs and Work Instructions, maintain training compliance and accurate timesheets • Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

🎯 Requirements

• Minimum of a BA or BS preferred • 3-4 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience • Ideally, experience in a regulatory area • Detailed understanding of clinical trial processes across Phases I-IV and ICH GCP • Detailed understanding of country-specific and local clinical trial submission processes and regulations • Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155) • Strong organizational and problem-solving skills • Proven ability to meet deadlines with high quality • Strong presentation, documentation, influencing, and written and spoken communication skills • Team-oriented approach • Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, email, and Internet • Ability to manage competing priorities in a dynamic, fast-paced environment • Demonstrated ability to work independently and as part of a team • English advanced

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Remote work arrangement (100% remote in Brazil)