Line Manager, Regulatory Affairs, Canada remote, This role combines people leadership and operational delivery, actively contributing to the execution of clinical trial regulatory activities. As a Line Manager & Regulatory Affairs Specialist, the employee will be responsible of overseeing Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and contractual timelines are met.

The Regulatory Affairs

Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials.

As Line

Management, the employee will be responsible for resource management and team development of direct reports. More specifically, the Line Manager, Regulatory Affairs/ Regulatory Affairs Specialist must: Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise.

Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. Peer review of documents and packages prepared by colleagues within regulatory team. Reviews 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.



Reviews site-level Informed Consent form documents as needed. Prepares or reviews study-specific regulatory documents/forms.

Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. Reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements. Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs Submits documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation.

Communicates activities performed out-of-scope to project team members and provides them with budgeting details related to said activity. Participates 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 helps 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.

Participate in process improvement initiatives. Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Bachelor’s degree (or equivalent) in a scientific discipline. 3-5 years (in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; Working knowledge of applicable regional / national country regulatory guidelines, IRB/IEC regulations Knowledge 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, required·Additional languages represent an asset Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No536/2014. Permanent full-time position Adaptable schedule Vacation Home-based position We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively.

As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

📌 Remote Line Manager, Regulatory Affairs, Canada, remote (Toronto)
🏢 Bilinguallink
📍 Toronto