Line Manager, Regulatory Affairs, EU remote

Line Manager, Regulatory Affairs (EU Remote)

Innovaderm Research Inc. is seeking a dynamic Line Manager for Regulatory Affairs to join our team. This is a remote position open to candidates based in Spain, Poland, or Germany, offering a permanent, full-time opportunity with a flexible schedule.

About the Role

This position blends people leadership with operational excellence, focusing on the execution of clinical trial regulatory activities. You will oversee Ethics Committee (EC) and Regulatory Authority (RA) submissions, ensuring compliance with regulations and meeting contractual timelines. As a Line Manager, you will be responsible for resource management and the professional development of your direct reports, fostering a positive and productive work environment.

Key Responsibilities

• Coordinate regulatory timelines and deadlines for all assigned projects related to RA and EC submissions.
• Provide expert regulatory support and advice to project teams, including project-specific local submission strategies.
• Guide clients on optimal submission strategies.
• Prepare and review core and country-specific packages for RA submissions (initial applications, amendments, notifications) in assigned countries.
• Prepare, manage, and track IRB/IEC submissions, including renewals, acting as the primary contact.
• Conduct peer reviews of documents and packages prepared by colleagues.
• Review regulatory documents and submissions from external subcontractors to ensure quality.
• Serve as the primary point of contact for regulatory bodies, IRB/IECs, Sponsors, investigative sites, subcontractors, and local teams for all submission-related matters.
• Develop and review Master Informed Consent Forms (ICFs) and country-specific ICFs.
• Prepare or review study-specific regulatory documents and forms.
• Manage and oversee translation requests with vendors.
• Submit and track Suspected Unexpected Serious Adverse Reactions (SUSARs) to relevant authorities and ethics committees.
• Perform regulatory review of essential documents and authorize regulatory release before investigational product shipment.
• Review country-specific labeling content for clinical trial drug supplies for regulatory conformity.
• Participate in kick-off meetings, client audits, and other project-related meetings.
• Submit documents to the Trial Master File (TMF) in a timely manner and ensure its completeness.
• Communicate out-of-scope activities and associated budgeting details to project team members.
• Maintain up-to-date knowledge of relevant regulations.
• Participate in functional and corporate initiatives and special projects.
• Support Regulatory Country Intelligence activities.
• Liaise with regulatory agencies and other experts on designated regulatory activities.
• Potentially provide presentations and training, and assist in developing tools and processes for the Regulatory Team.

Line Management Responsibilities

• Provide line management to direct reports, including orientation, professional development, performance appraisals, and mentoring.
• Manage and coordinate the resources and workloads of direct reports.
• Support staff by establishing goals, delegating tasks, and fostering skill development.
• Promote a positive work environment and motivate the team to achieve organizational goals.
• Participate in the hiring process for new employees.
• Implement productivity improvements and participate in process improvement initiatives.

Requirements

• Bachelor’s degree (or equivalent) in a scientific discipline.
• 3-5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
• Proven experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications.
• Working knowledge of applicable regional/national country regulatory guidelines and IRB/IEC regulations.
• Knowledge of Clinical Trials Information System (CTIS) at both local and regional levels within the EU.
• Functional staff management experience is an asset.
• Ability to develop others' skills and motivate team members.
• Excellent communication skills.
• Proficiency in Microsoft Office Suite.
• Fluency in English (oral and written); additional languages are an asset.
• Strong attention to detail and accuracy.
• Ability to organize work, prioritize assignments, and work under pressure.
• Versatility and comfort in a multitasking environment.
• Adherence to established timelines, expectations, priorities, and objectives.
• Good knowledge of Good Clinical Practices (GCP), applicable Health Canada and Food and Drug Administration (FDA) regulations, and Regulation (EU) No 536/2014.

What We Offer

• Permanent full-time position.
• Flexible schedule.
• Vacation allowance.
• Home-based position.
• Ongoing learning and development opportunities.

Indero (formerly Innovaderm) is a world-renowned expert in dermatology and rheumatology clinical research, with over 25 years of experience and a global footprint. We offer a stimulating work environment with values of collaboration, innovation, reliability, and responsiveness, along with attractive advancement opportunities.