Manager, Regulatory Affairs – EMEA

This is a fully remote position, open to applicants in Romania, +6 more countries.

📋 Description

• Assess study budgets and costs pertaining to contract negotiations.

• Engage in business development initiatives.

• Draft regulatory sections for proposals and feasibility assessments.

• Participate in bid defense presentations.

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

• Ensure proper approvals and maintain accurate compilation, management, and tracking of submissions.

• Offer expert regulatory guidance and contribute to regulatory project endeavors.

• Relay submission progress to Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs personnel.

• Assist in creating technical documents such as IMPDs and IBs.

• Evaluate documentation and provide recommendations to ensure adherence to ICH GCP and country-specific regulations.

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

• May oversee junior staff members.

⛳️ Requirements

• Demonstrated leadership and organizational management abilities.

• Strong skills in planning, strategizing, managing, monitoring, scheduling, and evaluation.

• Exceptional written and verbal communication capabilities.

• Competency in building relationships and supporting Business Development during in-person meetings.

• Excellent interpersonal skills in a dynamic, fast-paced, and deadline-driven environment.

• Capacity to manage multiple tasks in a rapidly evolving setting.

• A minimum of a four-year college degree with a focus in medical, biological, physical, health, pharmacy, or another related field; OR a two-year college degree or equivalent education/training (nursing degree or equivalent life science degree) along with eight years of experience in clinical research.

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

• Proficiency in cross-cultural communication.

• Proficient in 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 relevant law.

• Supportive and collaborative teams.

• A diverse and inclusive work environment.

• Opportunities for training, coaching, mentoring, and professional growth.