Manager, Regulatory Affairs – EMEA

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• 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

• 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

• 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