Regulatory Affairs Director

1 day ago


Toronto, Ontario, Canada Parexel Full time
Director, Regulatory Affairs

About the Role

Parexel is seeking a highly experienced Director, Regulatory Affairs to lead our regulatory affairs team. As a key member of our leadership team, you will be responsible for providing strategic guidance and technical expertise to ensure compliance with regulatory requirements.

Key Responsibilities

  • Foster a culture of compliance and excellence within the regulatory affairs team.
  • Develop and implement regulatory strategies to support business growth and expansion.
  • Provide expert advice on regulatory matters to cross-functional teams.
  • Manage and mentor a team of regulatory professionals to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Collaborate with internal stakeholders to ensure regulatory requirements are met and compliance is maintained.
  • Stay up-to-date with changing regulatory landscapes and ensure the team is aware of any new requirements or guidelines.
  • Develop and maintain relationships with regulatory agencies and industry partners.
  • Ensure high-quality deliverables and timely project completion.
  • Identify and mitigate risks associated with regulatory non-compliance.
  • Develop and implement processes to ensure regulatory compliance and efficiency.

Requirements

  • Minimum of 10-15 years of experience in regulatory affairs, with a strong background in the life sciences or consulting industries.
  • 8+ years of experience in people management and leadership within the clinical and/or nonclinical regulatory functions.
  • Advanced degree (MSc, PhD) preferred.

About Parexel

Parexel is an equal opportunity employer. We are committed to diversity and inclusion in the workplace. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.



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