Associate Director, Regulatory Affairs (Spain)

Associate Director, Regulatory Affairs (Spain)

Spain

CRO - Regulatory Affairs

Full time

The Associate Director, Regulatory Affairs is responsible for managing and overseeing the services provided by the Regulatory Affairs group in the assigned regions, ensuring compliance with Innovaderm’s standard operating procedures, applicable regulations, good clinical practices, and sponsor requirements.

Responsibilities include providing leadership on regulatory activities leading to the global start-up of clinical trials, planning and assigning work, overseeing the performance of direct reports, conducting annual reviews, addressing employee relations issues, and escalating issues as needed.

We are looking for someone who has :

• Experience as a lead and escalation point of contact for global projects.
• At least [X] years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and / or CRO industry.
• Experience with oversight of preparing and submitting part I and / or part II Clinical trial applications following EU CTR.

More specifically, the Associate Director, Regulatory Affairs must :

• Oversee Regulatory Affairs activities of direct reports and in assigned regions to ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements.
• Manage performance, establish clear objectives and performance indicators, conduct formal performance reviews, and develop direct reports.
• Plan regional resources by forecasting project needs and overseeing recruitment efforts to ensure adequate staffing, experience, and training.
• Ensure regional training of the team and oversee practices to ensure alignment across the team through adoption and use of all process and technology tools.
• Serve as a subject matter expert (SME) in regulatory affairs within the department and organization. Assist with development of submission strategies.
• Act as a senior point of contact for project teams when issues related to regulatory activities must be escalated, ensuring communication and resolution. Support sponsor interactions as required.
• Support strategic business expansion activities into new offerings and geographical regions.
• Review documents and submissions prepared by the regulatory team, ensuring completeness and timely responses to Health Authorities. Perform regulatory project tasks as needed.
• Lead departmental quality and process improvement initiatives, monitor and report quality issues, develop solutions, and liaise with cross-functional leads.
• Participate in RFPs and RFIs, outline regulatory strategies, evaluate project budgets, and present regulatory services during bid defenses.
• Monitor out-of-scope work, forecast and recognize departmental revenue, and evaluate budget metrics.
• Oversee implementation of systems related to departmental activities, including change management, documentation, and training.
• Manage vendors and subcontractors, ensuring quality standards before submissions.
• Write, review, and update SOPs, tools, and work instructions for assigned regions, ensuring optimal use of templates, processes, and tools.
• Maintain regulatory intelligence databases and participate in regulatory watch activities.
• Serve as a point of contact for client audits, regulatory inspections, and other meetings.
• Participate in corporate initiatives and special projects.
• Stay current with industry practices, regulatory requirements, and regional regulations relevant to the company’s interests.

REQUIREMENTS

Education :

• Bachelor’s degree (or equivalent) in life sciences or a related scientific discipline.

Experience :

• At least [X] years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and / or CRO industry, including [X] years in management roles.
• Experience in preparing, reviewing, and submitting Clinical Trial Applications and IRB / IEC packages.

Knowledge and skills :

• Solid knowledge of review and approval processes of applicable regulatory Health Authorities.
• Ability to assess impact of evolving information and provide guidance.
• Team leadership experience; line management experience is an asset.
• Excellent knowledge of Microsoft Office suite.
• Fluent in English with excellent oral and written communication skills; additional languages are an asset.
• Interpersonal and intercultural communication skills.
• Flexible risk approach and adaptability to changing business needs.
• High tolerance for ambiguity.
• Client-focused, problem-solving attitude.
• Respect for timelines, expectations, priorities, and objectives.
• Good knowledge of good clinical practices, and applicable regulations and guidelines (e.g., Health Canada, FDA).

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks :

• Permanent full-time position
• Company benefits package
• Ongoing learning and development

About Innovaderm

Innovaderm is a contract research organization (CRO) specializing in dermatology. Since its inception, our organization has built a solid reputation for quality research and exceeding client expectations. Based in Montreal, Innovaderm continues to grow and expand across North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations will be provided throughout the recruitment process upon request.

Only applicants legally authorized to work in Spain will be considered.

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