Associate Director, Regulatory Affairs (Spain)

Associate Director, Regulatory Affairs (Spain)

Location: Spain

Industry: CRO - Regulatory Affairs

Position Type: Full time

The Associate Director, Regulatory Affairs, is responsible for managing and overseeing the services provided by the Regulatory Affairs team in the assigned regions, ensuring compliance with Innovaderm’s SOPs, regulations, GCP, and sponsor requirements.

Responsibilities include providing leadership on global regulatory activities for clinical trial start-up, planning and assigning work, overseeing team performance, conducting reviews, and addressing employee relations issues.

Requirements include:

• Experience as a lead and escalation point for global projects.
• Several years of experience in clinical regulatory affairs within the pharmaceutical, biotech, or CRO industry.
• Experience with preparing and submitting Clinical Trial Applications following EU CTR.

Specific duties:

• Oversee regulatory activities of the team to ensure quality, timeliness, and compliance.
• Manage performance, set objectives, and develop team members.
• Plan resources and oversee recruitment for regional needs.
• Ensure regional training and process alignment.
• Serve as SME in regulatory affairs and assist with submission strategies.
• Act as senior contact for project issues and sponsor interactions.
• Support expansion into new regions and offerings.
• Review regulatory documents and submissions for completeness and timeliness.
• Lead quality and process improvements, monitor issues, and liaise with cross-functional teams.
• Participate in RFPs, evaluate budgets, and present services.
• Monitor departmental revenue and budget metrics.
• Oversee systems implementation, vendor management, and SOP updates.
• Maintain regulatory intelligence and prepare for audits and inspections.
• Engage in corporate initiatives and stay updated on industry regulations.

Qualifications:

• Bachelor’s degree in life sciences or related field.
• Several years of regulatory experience, including management roles.
• Experience with Clinical Trial Applications and IRB/IEC submissions.

Skills:

• Knowledge of regulatory approval processes.
• Leadership and team management skills.
• Proficiency in Microsoft Office.
• Fluent in English; additional languages are a plus.
• Strong interpersonal, communication, and intercultural skills.
• Adaptability, problem-solving, and client-focused attitude.
• Understanding of GCP and regional regulations.

Company & Benefits:

Innovaderm offers a collaborative and innovative work environment with opportunities for growth, benefits, and ongoing learning. The position is permanent, full-time, and based in Montreal, with a focus on dermatology research.

We are committed to diversity and equal opportunity. Accommodations are available during recruitment. Only applicants authorized to work in Spain will be considered.

J-18808-Ljbffr