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Strategic Regulatory Affairs Director

2 months ago

Toronto, Ontario, Canada EVERSANA Full time
Job Summary

We are seeking a highly experienced and skilled Strategic Regulatory Affairs Director to join our team at EVERSANA. As a key member of our organization, you will be responsible for leading our regulatory affairs efforts and ensuring compliance with all relevant regulations and guidelines.

Key Responsibilities
  • Develop and implement strategic plans for regulatory affairs, including the development and submission of clinical trial applications, new drug submissions, and supplemental new drug submissions.
  • Oversee the regulatory strategy and Health Canada submissions for EVERSANA clients, ensuring compliance with all relevant regulations and guidelines.
  • Set clear goals and objectives for work produced internally and externally, ensuring effective plans and measurable outcomes.
  • Recruit and onboard talent, ensuring all employees and contractors adhere to our cultural beliefs and values.
  • Manage performance, work processes, and other resources to ensure effective work delivery.
  • Develop people and a talent pipeline to fill future business needs, including developing new customer projects and relationships.
  • Plan, organize, and coordinate input into proposals, manage quotes for contractors/internal team to ensure target profitability.
  • Ensure effective communication within the team and collaborate with internal departments to deliver on shared projects.
  • Perform other duties as assigned.
Requirements
  • Masters-level education required.
  • 20+ years of experience in various pharmaceutical roles in Canada.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Teamwork and collaboration.
  • Critical thinking and problem-solving skills.
  • Strategic business thinking.
  • Consulting skills.
  • Project management knowledge.
Preferred Qualifications
  • MSC, MBA, or MBiotec degree.
  • 20+ years of experience in the Canadian industry, including leadership roles.
Work Environment

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

While performing the essential functions of this job, the employee is frequently required to reach, grasp, stand, and/or sit for long periods of time (up to 90% of the shift), walk, talk, and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Currently, work-from-home is available with attendance expected at team meetings in either Toronto or Burlington at the EVERSANA offices.

Benefits
  • Competitive wages as part of our total rewards program.
  • Generous employer matching retirement solutions.
  • Leading health, dental, and vision insurance products.
  • Employer-funded tuition reimbursement.
  • Global workplace flexibility.
  • Generous paid time off, including company holidays.
  • Company-provided training and development, including LinkedIn Learning.
  • Employee assistant programs, offering financial, work-life balance, legal solutions, and more to employees at no cost 24-7-365.