Line Manager, Regulatory Affairs

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

📋 Description

• Oversee regulatory timelines and deadlines for all assigned projects intended for RA and EC submissions.

• Offer regulatory support and insights to project teams; delivers project-specific local submission strategies and technical knowledge.

• Advise clients on submission strategies.

• Prepare and review core packages and country-specific submissions for RA (initial applications, amendment packages, and notifications) in designated countries to ensure compliance.

• Manage and track IRB/IEC submissions (including renewals); serves as the main contact for the central IRB/IEC.

• Conduct peer reviews of documents and packages prepared by colleagues within the regulatory team.

• Examine regulatory documents and submissions created externally by subcontractors (e.g., partner CROs, regulatory vendors) to maintain high quality standards prior to submission to RA and IEC.

• Act as the point of contact for regulatory bodies, IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams regarding all aspects of study regulatory submissions.

• Develop and review the Master Informed Consent Form (ICF), as necessary, along with Country ICFs.

• Assess site-level Informed Consent form documents as required.

• Prepare or review study-specific regulatory documents/forms.

• Oversee translations and requests with vendors.

• Submit and monitor SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, in accordance with study scope.

• Conduct regulatory reviews of essential documents and authorize regulatory release prior to the shipment of investigational products to clinical sites.

• Review country-specific labeling content for clinical trial drug supplies to ensure compliance with regional regulatory requirements.

• Participate in Kick-off meetings, client audits, and other project-related meetings based on company/client needs.

• Timely submit documents to TMF during the trial and ensure assigned sections are complete by performing completeness reconciliation.

• Communicate activities performed outside of the scope to project team members and provide budgeting details related to such activities.

• Maintain comprehensive knowledge of regulations in the company's areas of interest.

• Engage in function and/or corporate initiatives and special project assignments.

• Support Regulatory Country Intelligence efforts.

• Liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities as required.

• May deliver presentations, training, or assist in developing tools and processes for the Regulatory Team or other cross-functional teams.

• Provide line management to direct reports, including new-hire orientation, professional development, performance evaluations, and employee counseling/mentoring.

• Manage and coordinate resources and workloads of direct reports.

• Support staff by setting goals that enhance knowledge and skill levels and by delegating tasks appropriate to skill levels.

• Foster a positive work environment and inspire the team to achieve organizational objectives.

• Participate in the hiring process for new employees.

• Provide leadership and implement productivity enhancements to ensure optimal resource utilization.

• Engage in process improvement initiatives.

⛳️ Requirements

• Bachelor’s degree (or equivalent) in a scientific field.

• 3-5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, and/or CRO sectors.

• Proficient in preparing and submitting IRB/IEC packages and/or Clinical Trial Applications.

• Familiarity with applicable regional/national regulatory guidelines and IRB/IEC regulations.

• Knowledge of CTIS at local and regional levels.

• Experience in functional staff management is advantageous.

• Excellent proficiency in Microsoft Office Suite.

• Fluency in English with strong oral and written communication skills.

• Proficiency in additional languages is considered a benefit.

• Strong attention to detail and accuracy in work.

• Ability to organize tasks, prioritize different assignments, and work effectively under pressure.

• Adhere to established timelines, expectations, priorities, and objectives.

• Solid understanding of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA) regulations, and Regulation (EU) No 536/2014.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Home-based position.

• Continuous learning and development opportunities.