October 2
• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required. • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required • Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information • Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval • Provides ICH GCP guidance, advice and training to internal and external clients • Serve as representative of Global Regulatory Affairs at business development meetings
• 5+ years or more relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones • Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel including overnight stays
Apply NowOctober 2
1001 - 5000
Regulatory Manager providing guidance for clinical trials at Precision Medicine Group.
🇨🇦 Canada – Remote
💵 $113k - $152.8k / year
💰 $35.2M Venture Round on 2021-03
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
August 1
201 - 500
Promotes compliance in Clinical Research through training and quality assurance initiatives.