Manager, Regulatory Affairs – EMEA

This is a fully remote position, open to applicants in Romania.

📋 Description

• Evaluate study budgets and cost considerations pertinent to contract negotiations.

• Engage in business development initiatives.

• Draft regulatory components for proposals and feasibility assessments.

• Participate in bid defense presentations.

• Oversee and manage submissions to regulatory and ethics committees across EMEA, Asia Pacific, and Latin America.

• Ensure approvals are maintained and submissions are accurately compiled, managed, and tracked.

• Offer expert regulatory guidance and support regulatory project tasks.

• Update Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs staff on submission status.

• Assist in the creation of technical documentation, including IMPDs and IBs.

• Assess documentation and provide recommendations to uphold compliance with ICH GCP and country-specific regulations.

• Deliver training, coaching, and mentorship to junior team members.

• May be responsible for line management of junior staff.

⛳️ Requirements

• Demonstrated leadership and organizational management capabilities.

• Strong abilities in planning, strategizing, managing, monitoring, scheduling, and evaluating.

• Exceptional written and verbal communication skills.

• Competence in relationship-building and supporting Business Development during in-person meetings.

• Excellent interpersonal skills suitable for a dynamic, deadline-driven, and evolving environment.

• Capacity to manage multiple tasks in a fast-paced and continuously changing setting.

• At least a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related scientific field, OR a two-year college degree or equivalent education/training (such as a nursing degree or similar life science degree) accompanied by eight years of experience in clinical research.

• Minimum of 5-7 years in the pharmaceutical/CRO sector, showcasing senior-level regulatory or clinical start-up experience.

• Skilled in cross-cultural communication.

• Proficient in both spoken and written English.

🏝️ Benefits

• Equal employment opportunities irrespective 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 any other class protected by applicable law.

• Supportive and collaborative team atmosphere.

• Diverse and inclusive workplace culture.

• Flexible remote work options.