Regulatory Intelligence Manager Temp

This role involves leading proactive monitoring and surveillance on changes in the global regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. The position will oversee and support daily operations and governance, ensuring that all processes and activities related to surveillance and assessment are conducted efficiently and effectively. This is a 7 month contract role.,

• Monitor and analyze the external regulatory environment, including guidelines and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders
• Lead the comprehensive day-to-day oversight and management of Reg Intel Systems and Dashboards - Ensure seamless operation, maintenance, and continuous improvement of these tools, which are needed for monitoring and analyzing regulatory trends and compliance requirements.
• Work closely with cross-functional teams, including IT, GDS, compliance, regulatory affairs and other functions as well as external vendors to ensure that the Reg Intel Systems and dashboards are aligned with organizational goals and regulatory requirements.
• Identify business critical aspects and communicate effectively to internal stakeholders
• Collaborate with cross-functional teams to align regulatory intelligence with business objectives
• Lead cross-functional teams to streamline Regulatory Intelligence-related processes and improve operational efficiency.
• Stay abreast of the latest technological advancements and regulatory changes. Proactively seek out and implement innovative solutions to enhance the functionality and effectiveness of the Reg Intel Systems and dashboards.
• Implement best practices and innovative solutions to enhance regulatory compliance and efficiency.
• Conduct regular reviews and assessments to ensure continuous improvement in regulatory processes.
• Provide ongoing support and training to users of the Reg Intel Systems and dashboards. Develop comprehensive training materials and conduct workshops to ensure that all users are proficient in utilizing these tools to their full potential
• Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.
  
  Minimum Bachelor's Degree in Sciences, Engineering or other similar discipline
• Project Management/Six Sigma certification a plus, Minimum 5-6 years of experience in the biotech/pharmaceutical industry or Health Authority experience (with a focus in Regulatory, Drug Safety and/or Clinical preferred)
• Good understanding of the drug development and commercialization processes, as well major Health Authority regulations governing these processes (such as FDA, EMA, Health Canada, PMDA etc.)
• Proficiency in regulatory intelligence tools and systems, with the ability to implement and optimize these technologies.
• Strong analytical skills with the ability to interpret complex regulatory information and provide actionable insights.
• Strong project management skills, including the ability to manage multiple projects simultaneously and meet deadlines.
• Strong problem-solving skills with the ability to make informed decisions based on regulatory intelligence and data analysis.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
• Demonstrated leadership skills with experience in managing and mentoring a team of regulatory professionals.
• High level of attention to detail and accuracy in regulatory documentation and reporting.
• Ability to adapt to changing regulatory landscapes and organizational priorities.