Worldwide Clinical Trials logo
Worldwide Clinical Trials

As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.

Senior Manager, Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

2 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

Senior Manager, Regulatory Affairs

Worldwide Clinical Trials

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions • Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. • Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements • Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

Job Requirements

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
  • Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research (e.g., CRA, Reg Affairs)
  • Minimum 5-7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
  • Proficient in cross-cultural communication and proficient in both spoken and written English.

Benefits

  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

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