Specialist, Regulatory & Site Activation

Job Summary

Subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects. Responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.

Responsibilities

• Tasks may include but are not limited to: Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
• Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
• Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements
• Review and provide advice on country timelines for the assigned studies
• Effectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissions
• Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines and relevant study specific plans.
• Track study-specific regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the RAM
• Proactively identify risks and generate mitigation strategies at country/site level
• Advise the RAM/project team about appropriate country regulatory strategies
• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
• Provide timely and relevant updates of changing regulatory requirements, support on interpretation of new regulations, and maintain regulatory intelligence database for the assigned country
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations
• Where required provide local QC of submission dossiers prior to dispatch
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Perform other duties as assigned.
• The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other Skills and Abilities

• Strong organizational and management skills
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
• Self-motivated learning about current regulatory processes and intelligence
• Excellent written and verbal communication skills to clearly and concisely present information
• Proactive by identifying potential issues in the process and anticipating solutions
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
• Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
• Team-oriented work style; seeks and gives guidance to others
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and changing environment
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Aptitude for contemporary digital systems is helpful

Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum two year of experience in clinical research, preferably in site activation and/or regulatory-related function
• Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
• Multilingualism preferred; fluent in local language; working knowledge of English
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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