Line Manager, Regulatory Affairs

Innovaderm Research Inc.

. Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions .

Posted 6/1/2026full-timeRemote • 🇪🇸 SpainMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions
Provide regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise
Provide guidance to the client on submissions strategies
Prepare/review core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance
Prepare, manage, and track IRB/IEC submissions (including renewals); acts as the primary point of contact for the central IRB/IEC
Peer review of documents and packages prepared by colleagues within the regulatory team
Review regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC
Point of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for all aspects related to study regulatory submissions
Develop/review Master Informed Consent Form (ICF), as applicable, and Country ICFs
Review site-level Informed Consent form documents as needed
Prepare or review study-specific regulatory documents/forms
Manage/oversee translations and requests with vendor
Submit and track SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope
Perform regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites
Review country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements
Participate in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
Submit documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation
Communicate activities performed out-of-scope to project team members and provides them with budgeting details related to said activity
Maintain high level knowledge about regulations in the area of company interest
Participate in function and/or corporate initiatives and special project assignments
Support Regulatory Country Intelligence activities
Communicate/liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities as required
May provide presentations, training or help to develop 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 appraisals, and employee counseling/mentoring
Management and coordination of resources and workloads of direct reports
Supports staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level
Promote a positive work environment and motivate the team to achieve organization goals
Participate in the hiring process of new employees
Provide leadership and implement productivity improvements to ensure optimal utilization of resources
Participate in process improvement initiatives

Requirements

What you’ll need

Bachelor’s degree (or equivalent) in a scientific discipline
3-5 years in clinical regulatory affairs in 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, IRB/IEC regulations
Knowledge of CTIS on a local and regional level
Functional staff management experience an asset
Excellent knowledge of Microsoft Office suite
Fluency in English with excellent oral and written skills
Additional languages represent an asset
Attention to detail and accuracy in work
Ability to organize own work, prioritize different assignments, and work under pressure
Respect established timelines, expectations, priorities, and objectives
Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014

Benefits

Comp & perks

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

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Hard Skills & Tools

regulatory submissionsIRB/IEC submissionsclinical trial applicationsregulatory document reviewMaster Informed Consent Form (ICF)SUSAR trackingclinical trial drug labelinggood clinical practicesHealth Canada regulationsFDA regulations

Soft Skills

communicationleadershiporganizational skillsattention to detailability to prioritizeteam motivationperformance managementemployee counselinggoal settingprocess improvement