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CTIS Submission Manager

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

103 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

CTIS Submission Manager

ICON plc

• Leading the preparation, submission, and maintenance of regulatory documents for EU CTIS submissions. • Providing expertise and guidance on regulatory requirements and standards to internal teams. • Interfacing with regulatory agencies to address inquiries, submissions, and approvals. • Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks. • Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.

Job Requirements

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Strong knowledge of global regulatory requirements and guidelines for clinical trials.
  • Proven ability to manage regulatory submissions and interactions with regulatory agencies.
  • Excellent communication, attention to detail, and problem-solving skills.

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.

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