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Worldwide Clinical Trials
Worldwide Clinical Trials
1,001 – 5,000 Employees
H1B Visa SponsorConsultingHealthcareLogistics
Worldwide Clinical Trials is a global contract research organization that supports pharmaceutical and biotechnology companies throughout the drug development lifecycle. With more than 30 years of experience, the company provides clinical monitoring, data management, patient recruitment, and regulatory consulting across therapeutic areas including oncology, cardiology, and rare diseases. Its approach combines broad clinical trial expertise with personalized support and tailored solutions for complex studies.
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Manager, Regulatory Affairs - EMEA (Romania Remote)

Lead regulatory affairs activities for clinical-trial submissions and approvals across EMEA, Asia Pacific, and Latin America. Support CRO business development, compliance, regulatory project delivery, and the development of junior staff.

ESSpainFRFranceGBUnited KingdomHRCroatiaPLPolandRORomaniaRSSerbiaRemoteFull-timeMiddleSeniorEnglish RequiredCompliance
Google Cloud Platform

Description

  • Assess study budgets and costing to support contract negotiations
  • Contribute to business development initiatives
  • Draft regulatory sections for proposals and feasibility reports
  • Participate in bid defense meetings
  • Coordinate and oversee regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America
  • Maintain approvals and ensure submissions are accurately compiled, managed, and tracked
  • Deliver regulatory expertise and support regulatory project activities
  • Update Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs teams on submission status
  • Support the preparation of technical documents, including IMPDs and IBs
  • Review documentation and recommend actions to meet ICH GCP and country-specific requirements
  • Train, coach, and mentor junior team members
  • Potentially manage junior staff directly

Requirements

  • Demonstrated leadership and organizational management capability
  • Strong skills in planning, strategy, management, monitoring, scheduling, and critical review
  • Excellent written and verbal communication abilities
  • Skilled at building relationships and comfortable supporting Business Development in face-to-face meetings
  • Strong interpersonal skills for a fast-paced, deadline-driven, changing environment
  • Able to manage multiple priorities in a fast-moving and continually changing environment
  • Four-year college education concentrated in medical, biological, physical, health, pharmacy, or a related science; alternatively, a two-year college education or equivalent training, such as a nursing or life science degree, plus eight years of clinical research experience
  • At least 5–7 years of experience in the pharmaceutical or CRO industry, including senior-level regulatory or clinical start-up experience
  • Proficient in cross-cultural communication
  • Proficient in spoken and written English

Benefits

  • Equal employment opportunities are provided regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or another class protected by applicable law
  • Supportive and collaborative teams
  • Diverse and inclusive work environment
  • Training, coaching, mentoring, and professional development opportunities

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