Hybrid Manager, Regulatory Operations – eCTD Operations

Posted last week

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About the role

  • Lead the Regulatory Operations project team, providing guidance on regulatory standards, advising on strategies, delivering training, recruitment, workforce planning, and personal development
  • Manage eCTD submissions, ensuring they are tracked accurately and in full compliance with regulatory guidelines
  • Participate in development of internal processes for eCTD
  • Recruitment and training of regulatory personnel for eCTD submissions
  • Oversee the global publishing, compilation, filing, and maintenance of regulatory submissions
  • Maintain positive and productive relationships with internal and external stakeholders, including regulatory agencies, clients, colleagues, and staff
  • Coordinate with country-specific regulatory affairs personnel to support international submissions and registrations
  • Engage with regulatory agencies and standards development bodies (such as ICH, CDISC, and HL7) to stay informed about new developments in electronic regulatory standards
  • Lead the implementation of new regulatory standards, processes, and SOPs within the department

Requirements

  • Bachelor's degree or equivalent experience in a relevant field
  • Proven experience working with eCTD submissions
  • Demonstrated ability to produce high-quality work with strong attention to detail
  • Experienced in creating and delivering effective training materials
  • Strong leadership skills with the ability to support and guide team members with both compassion and confidence.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Job title

Manager, Regulatory Operations – eCTD Operations

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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