Regulatory and Start Up Specialist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory and Start Up Specialist coordinating Site Activation activities in Switzerland and Belgium for a clinical research provider. Ensuring adherence to regulations and project timelines while supporting project teams.
Responsibilities:
- Perform tasks at a country level associated with Site Activation (SA) activities
- Ensure adherence to standard operating procedures (SOPs)
- Serve as Single Point of Contact (SPOC) in assigned studies
- Perform start-up and site activation activities
- Distribute completed documents to sites and teams
- Prepare site regulatory documents, ensuring completeness and accuracy
- Maintain internal systems, databases, and tracking tools
- Review and provide feedback on site performance metrics
- Review, track, and follow-up on document approvals and executions
- Provide local expertise to SAMs and project team
Requirements:
- Bachelor’s Degree in life sciences or a related field
- 3 years’ clinical research or other relevant experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs, and company’s Corporate Standards
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
Benefits:
- Home Based role
- Requires German language fluency
- Requires submissions experience in Switzerland and/or Belgium
Similar Jobs
Global Regulatory Lead, PDx
Global Regulatory Lead overseeing pharmaceutical diagnostics from pre-clinical to registration in global markets. Leading regulatory strategy for new product introductions and compliance obligations.
Manager, Regulatory Compliance
Manager of Regulatory Compliance leading U.S. sportsbook trading operations at DraftKings. Ensuring compliance across jurisdictions and managing a team in a fast-paced environment.
Risk and Compliance Manager – Retail Broking
Risk and Compliance Manager supporting compliance obligations for retail broking businesses in the UK. Providing regulatory guidance while working closely with the Risk & Compliance team remotely.
Regulatory Lead – Mount Nansen Remediation
Regulatory Lead overseeing environmental assessments and permitting for Mount Nansen Remediation project. Leading collaboration between technical teams and regulatory bodies.
Regulatory Affairs Associate
Regulatory Affairs Associate for Parexel developing and publishing regulatory submissions to health authorities. Collaborating with stakeholders to ensure compliance and quality in documentation.
IT Compliance Specialist, SISP
IT Compliance Specialist advancing IT Compliance program at Sedgwick. Conducting risk assessments, collaborating with stakeholders, and ensuring regulatory compliance.
Associate Director – Global Compliance Platform
Associate Director overseeing Amgen's global compliance platform (C3) for healthcare compliance requirements. Leading strategy, governance, and operations to optimize compliance processes globally.
Trade Compliance Specialist
Trade Compliance Specialist reviewing and ensuring compliance of export orders and documentation for corporate clients. Collaborating with partners to maintain regulatory standards and documentation accuracy.
Medicare Compliance, Advertising Filing Specialist
Medicare Compliance & Advertising Filing Specialist managing all Medicare advertising submissions through HPMS. Ensuring compliance with CMS guidelines and managing material submissions across multiple carriers.
Senior Director – Contracts Compliance & Operations
Senior Director overseeing the contract compliance program and operational functions at Amentum. Lead initiatives to enhance efficiency and ensure adherence to government regulations.
Senior Director, Global Trade Compliance
Senior Director leading global trade compliance programs and teams at Beckman Coulter Diagnostics. Driving strategy and operational efficiency in a dynamic global business environment with compliance expertise.
Senior Compliance Officer
Senior Compliance Officer overseeing financial services compliance at Acorns. Leading regulatory strategies and ensuring adherence to regulations for a financial wellness platform.
Credentialing & Compliance Lead
Credentialing & Compliance Lead responsible for the Medicare DMEPOS credentialing lifecycle and compliance activities. Facilitating customer interactions and maintaining regulatory standards within a fast-growing startup.
BESS Product Compliance Engineer
Software Solutions Engineer focusing on deploying VaultOS Power Plant Controller in Australia. Collaborating with global teams to develop utility-scale energy storage systems.
Data Protection, Compliance & Transformation Specialist
Referent für Datenschutz, Compliance und Transformation bei Linimed Gruppe GmbH. Verantwortung für operative Umsetzung und Weiterentwicklung der Prozesse im digitalen Bereich.
Business License Compliance Manager
Business License Compliance Manager at Apex Companies ensuring compliance with business licensing across jurisdictions. Overseeing licensing processes, renewals, and regulatory requirements with internal stakeholders.
Manager, Insurance Compliance
Manager, Insurance Compliance responsible for insurance compliance with GSE and HUD lenders. Utilizing a compliance automation platform for efficient portfolio management and strategic client support.
Insurance Compliance Analyst
Analyst handling insurance compliance operations within technology-driven environment supporting GSE and HUD lender portfolios. Collaborating with senior team members for high-quality delivery and improvement.
Compliance Analyst, Research Compliance
Compliance Analyst coordinating export control compliance operations at City of Hope. Ensuring adherence to federal international compliance laws and regulations in the research sector.
Senior Compliance Analyst, Research Compliance
Senior Compliance Analyst at City of Hope ensuring compliance in research activities and regulatory standards. Conducting audits, documenting findings, and assisting in investigations of non-compliance issues.