Altis Recruitment is seeking a Director, Regulatory Affairs for our client in the pharmaceutical industry. The successful incumbent will oversee and ensure compliance of all clinical studies with relevant regulations, aligning with the organization’s mission, values, and strategic goals. This position will lead the Regulatory Affairs team, providing strategic guidance and operational oversight on regulatory compliance across multiple clinical sites and study phases.

Roles and Responsibilities

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.
• Provide leadership to the Regulatory Affairs team, guiding them through all stages of clinical study management.

2. 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.
• Communicate company information to the Regulatory Affairs team, ensuring alignment with organizational goals and updates.
• Approve salary, bonuses, and merit increases, and oversee employee attendance, including vacations and sick leave.
• Address and resolve staff concerns and issues with clarity and promptness, fostering a positive work environment.
• Provide guidance on company policies and procedures, promoting compliance and a safe workplace in line with the Occupational Health and Safety Act.
• Drive a collaborative, professional environment that values confidentiality and teamwork.

3. Cross-Functional Collaboration

• Work across departments to ensure that regulatory activities align with the organization’s broader strategic objectives.
• Ensure adherence to all company policies, health, and safety standards while maintaining regulatory documentation integrity.

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.
• Proficient in Microsoft Office Suite and other relevant software tools.
• Strong understanding of regulatory requirements for clinical studies and medical research, including familiarity with  Health Canada and FDA standards.

Education

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

Benefits

• 3 weeks' vacation + holiday closure 
• Personal days, 10 stat holidays off and sick days. 
• Comprehensive benefits plan (health, dental & vision) 
• RRSP Matching up to 3% after 3 months