Manager, Regulatory Affairs – EMEA

Lifelancer

. Review study budgets and costing related to contract negotiation .

Posted 9/21/2026full-timeRemote • RomaniaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance within the pharmaceutical and CRO industries, with strong leadership and organizational management capabilities. Proficient in cross-cultural communication and relationship-building to support business development and project management.

Highest-signal resume keywords

Regulatory Submissions ManagementICH GCP ComplianceLeadership and Organizational ManagementClinical Research ExperienceCross-Cultural Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Proposal PreparationBudget Review and CostingTechnical Documentation (IMPDs, IBs)Project ManagementContract Negotiation

Soft Skills

Excellent Written and Verbal CommunicationInterpersonal SkillsRelationship BuildingPlanning and StrategizingCoaching and Mentoring

Industry Keywords

Pharmaceutical IndustryCRO IndustryClinical Start-Up ExperienceEMEAAsia PacificLatin America

About the role

Key responsibilities & impact

Review study budgets and costing related to contract negotiation
Participate in business development activities
Prepare regulatory sections of proposals and feasibility reports
Attend bid defense meetings
Coordinate and manage regulatory and ethics committee submissions throughout EMEA, Asia Pacific and Latin America
Maintain approvals and accurately compile, manage, and track submissions
Provide expert regulatory advice and contribute to regulatory project work
Communicate submission status with Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs staff
Contribute to technical documentation such as IMPDs and IBs
Review documentation and make recommendations to ensure compliance with ICH GCP and country-specific requirements
Provide training, coaching, and mentoring to junior staff
May line manage junior staff

Requirements

What you’ll need

Clearly proven leadership and organizational management skills
Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
Excellent written and verbal communication skills
Relationship-building competency and comfort supporting Business Development at face-to-face meetings
Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
Ability to handle multiple tasks in a fast-paced and constantly changing environment
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or another 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
Minimum 5-7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
Proficient in cross-cultural communication
Proficient in spoken and written English

Benefits

Comp & perks

Equal employment opportunities 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 other class protected by applicable law
Supportive and cohesive teams
Diverse and inclusive work environment
Remote work arrangement