Senior Manager, Regulatory Affairs

Worldwide Clinical Trials

Senior Manager in Regulatory Affairs leading regulatory submissions for clinical trials at Worldwide Clinical Trials. Managing approvals and collaborating across global teams in EMEA, Asia Pacific, and LATAM.

Posted 5/28/2026full-timeRemote • 🇵🇱 PolandSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Comp & perks

Health insurance
401(k) matching
Professional development opportunities
Flexible working hours
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionscontract negotiationbudget reviewtechnical documentationIMPDsIBscomplianceICH GCPproject managementclinical research

Soft Skills

communicationcoachingmentoringcross-cultural communicationleadershipteam managementorganizational skillsinterpersonal skillsproblem-solvingtraining