Line Manager, Regulatory Affairs (EU Remote)

Description

This role combines people leadership with operational delivery, actively contributing to the execution of clinical trial regulatory activities. As a Line Manager & Regulatory Affairs Specialist, you will oversee Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance with regulations and timely achievement of contractual deadlines. You will provide leadership for assigned projects, manage resources, and foster team development.

Responsibilities

• Coordinate regulatory timelines and deadlines for RA and EC submissions for all assigned projects.
• Provide regulatory support and advice to project teams, offering project-specific local submission strategies and technical expertise.
• Guide clients on submission strategies.
• Prepare and review core and country packages for RA submissions (initial applications, amendments, notifications) in assigned countries, ensuring compliance.
• Prepare, manage, and track IRB/IEC submissions (including renewals), acting as the primary contact for the central IRB/IEC.
• Peer review documents and packages prepared by colleagues within the regulatory team.
• Review regulatory documents and submissions created by external subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality before submission.
• Serve as the point of contact for regulatory bodies, IRB/IECs, Sponsors, investigative sites, subcontractors, and local teams for all study regulatory submission aspects.
• Develop/review Master Informed Consent Form (ICF) and Country ICFs, as applicable.
• Review site-level Informed Consent form documents as needed.
• Prepare or review study-specific regulatory documents/forms.
• Manage and oversee translations and requests with vendors.
• Submit and track SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope.
• Perform regulatory review of essential documents and authorize regulatory release prior to investigational product shipment to clinical sites.
• Review country-specific labeling content for clinical trial drug supplies to ensure conformity with regional regulatory requirements.
• Participate in Kick-off meetings, client audits, and other project-related meetings as needed.
• Submit documents to the TMF in a timely manner during the trial and ensure TMF completeness through reconciliation.
• Communicate out-of-scope activities to project team members and provide related budgeting details.
• Maintain high-level knowledge of regulations in the company's areas of interest.
• Participate in functional and/or corporate initiatives and special project assignments.
• Support Regulatory Country Intelligence activities.
• Liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities.
• May provide presentations, training, or assist in developing tools and processes for the Regulatory Team or other cross-functional teams.

Line Management Responsibilities:

• Provide line management to direct reports, including onboarding, professional development, performance appraisals, and employee counseling/mentoring.
• Manage and coordinate resources and workloads of direct reports.
• Support staff by establishing goals for knowledge and skill enhancement and delegating tasks commensurate with skill levels.
• Promote a positive work environment and motivate the team to achieve organizational goals.
• Participate in the hiring process for new employees.
• Provide leadership and implement productivity improvements to ensure optimal resource utilization. Participate in process improvement initiatives.

Note: Employees may be assigned additional responsibilities based on experience, qualifications, and training.

Requirements

Education:

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

Experience:

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

• EU: Knowledge of CTIS at both local and regional levels.
• Functional staff management experience is an asset.
• Ability to develop the skills of others and motivate team members.
• Excellent communication skills.
• Excellent knowledge of Microsoft Office suite.
• Fluency in English with excellent oral and written skills is required. Additional languages are an asset.
• Attention to detail and accuracy in work.
• Ability to organize own work, prioritize different assignments, and work under pressure.
• Versatile and comfortable in a multitasking environment.
• Respect 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.

Our Company

The Work Environment

At Indero, you will collaborate with brilliant and driven colleagues. Our values—collaboration, innovation, reliability, and responsiveness—drive our stimulating work environment and attractive advancement opportunities.

Perks:

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

About Indero:

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. With over two decades of experience across a broad range of indications, patient populations, administration routes, and drug classes, Indero has a global footprint. As a dual-focus CRO for dermatology and rheumatology, Indero offers a full-service approach from protocol design to trial monitoring and biometrics. Our capabilities span North America, Europe, Asia Pacific, and Latin America, supported by extensive investigator and patient relationships, and a dedicated research clinic. Indero is committed to equitable treatment and equal opportunity, providing accommodations for applicants with disabilities upon request. Indero only accepts applicants who can legally work in Europe.