Senior Country Regulatory Specialist

Job not on LinkedIn

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 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 country regulatory operations from study startup through project end • Provide expertise in country ethics and regulatory submissions within timelines, budgets, and quality standards • Serve as the main country-level contact with Regulatory Authorities and Ethics Committees under project leadership • 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 expertise for business development presentations and site selection • Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks • Prepare and submit Central Ethics Committee, Local Ethics Committee, Regulatory Authority, hospital, amendment, notification, and safety submissions • Interact with Regulatory Authorities and Ethics Committees and coordinate query responses • Serve as country-level regulatory SME throughout assigned projects • Ensure relevant documents are submitted to the Trial Master File • Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change • Develop or support local country regulation training materials • Train and mentor junior Country Regulatory Specialists • Support Procurement in managing Ethics/IRB vendors when required • Provide input to SOPs and Work Instructions and drive continuous quality improvement • Review SOPs and Work Instructions, maintain training compliance, and report timesheets accurately • Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

🎯 Requirements

• Minimum of a BA or BS preferred • 5-6 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience • Detailed understanding of clinical trial process across Phases I-IV and ICH GCP • Detailed understanding of clinical trial submission processes per-country and local regulations • Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155) • Strong organizational and problem-solving skills • Strong presentation, documentation, influencing, and communication skills • Team-oriented approach • Knowledge and interpersonal skills necessary to train and mentor junior Country Regulatory Specialists • 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 • Ability to work independently and as part of a team

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate