Regulatory Clinical Trials Operations Manager

6 days ago

Nairobi, Kenya beBeeClinical Full time $80,000 - $120,000

We are seeking a skilled Regulatory Clinical Trials Operations Manager to join our team. As a key member of our organization, you will be responsible for leading the timely and compliant delivery of clinical trial applications to health authorities and central ethics committees.

Your primary focus will be on managing project activities for clinical trials across multiple markets, territories, and phases. You will work closely with global submission and portfolio managers, as well as partners and third-party organizations, to ensure regulatory and central ethics compliance.

Key Responsibilities:
  • Drive regional submission management activities for assigned protocols, collaborating with global teams and external partners to ensure timely delivery of submissions.
  • Support and lead efforts to maintain high-quality components and submissions that meet industry, agency, and format guidelines, regulatory strategies, policies, and timelines.
  • Liaise with global stakeholders regarding essential documents, driving compliance and timely delivery in both health authority and central ethics submission and translation processes.
  • Prepare, review, and submit submissions to health authorities and regional central ethics, obtaining necessary authorizations and approvals for clinical trial conduct.
  • Coordinate translations for local documents required for submission, ensuring accuracy and compliance.
  • Manage submission build compilation, contributing to CTA and CE approvals, and authoring documentation as needed.
  • Serve as a subject matter expert, providing country-level intelligence on clinical trial regulatory matters and maintaining local country regulatory intelligence on the central repository.
  • Escalate and resolve issues impacting submission builds or logistics of global submission delivery to regional and local partners or health authorities.
Requirements:
  • Bachelor's degree in a relevant field such as life sciences, healthcare, or business administration.
  • Minimum 5 years of experience in regulatory affairs, clinical trials, or a related field.
  • Proven track record of managing complex projects, prioritizing tasks, and meeting deadlines.
  • Excellent communication and interpersonal skills, with ability to collaborate with cross-functional teams.
  • Familiarity with document management systems, regulatory guidelines, and industry standards.

Pfizer is an equal opportunity employer, committed to diversity and inclusion.

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