Regulatory Affairs Director

7 days ago

Ottawa, Ontario, Canada Altis Recruitment Full time
Regulatory Affairs Director

Altis Recruitment is seeking a seasoned Regulatory Affairs Director for our client in the pharmaceutical industry. The ideal candidate will oversee and ensure compliance of all clinical studies with relevant regulations, aligning with the organization's mission, values, and strategic goals.

  1. Regulatory Affairs Management
  • Develop and implement a comprehensive regulatory strategy to meet compliance standards for all clinical studies.
  • Oversee compliance with regulatory agencies, such as the Health Canada and FDA standards, ensuring all clinical activities meet required standards.
  • Supervise the start-up and ongoing maintenance processes for clinical studies across all sites.
  • Manage budget allocation and lead contract negotiations for clinical sites to align with financial goals.
  • Direct training initiatives and regulatory requirements for new and ongoing studies to ensure organizational consistency.
  1. Team Leadership and Development
  • Mentor, coach, and develop staff to support their professional growth and ensure team effectiveness.
  • Oversee the recruitment, hiring, and onboarding processes, including interview and candidate selection, to build a capable team.
  • Conduct performance evaluations, incorporating feedback from managers and team members to foster improvement.
  1. Cross-Functional Collaboration
  • Work across departments to ensure that regulatory activities align with the organization's broader strategic objectives.

Qualifications and Skills

  • Minimum of 7-10 years of experience in medical research, with demonstrated success in regulatory affairs.
  • At least 5-7 years of experience in team leadership and management within a regulatory or clinical research setting.

Education

  • Graduate degree in science, health, or a related field; or equivalent combination of education, training, and experience.

Benefits

  • Comprehensive benefits plan (health, dental & vision)
  • RRSP Matching up to 3% after 3 months

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