Regulatory Affairs Specialist – Canada

Jobtailor; Deutschland; Remote; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a Regulatory Affairs professional to oversee submissions and ensure regulatory compliance across Health Canada, FDA, and EU regulations. You will manage study start-up, coordinate timelines, and liaise with sponsors, CROs, and local teams.

The role emphasizes preparing Clinical Trial Applications, Ethics Committee packages, and regulatory documents, with strong English communication, detail orientation, and the ability to work under pressure.

Qualifikationen

• Bachelor's degree in a scientific discipline.
• 2–3 years of clinical research experience especially in regulatory affairs.
• Experience with Clinical Trial Applications and Ethics Committee packages.

Aufgaben

• Oversee regulatory submissions to regulatory authorities and ethics committees.
• Lead study start-up activities and ensure timelines are met.
• Coordinate regulatory timelines for Health Canada, FDA, and EU submissions.
• Review documents from subcontractors and CROs.
• Prepare or review Patient Information Sheets and Informed Consent Forms.
• Provide regulatory support and submission strategies to project teams.
• Maintain knowledge of Health Canada, FDA, and EU regulations.
• Participate in audits and kick-off meetings.

Kenntnisse

Regulatory Compliance

Clinical Trial Application Preparation

Ethics Committee Submission Management

GCP & ICH Standards

English Fluency

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

• Oversee central Ethics Committee, Regulatory Authority, and other submissions to ensure regulatory compliance and contractual timelines
• Provide leadership for assigned projects and activities leading to clinical trial start-up
• Coordinate regulatory timelines and deadlines for assigned Regulatory Authority and Ethics Committee submissions
• Oversee mainly North American submissions, with possible participation in EU and APAC submissions
• Review regulatory documents and submissions prepared by subcontractors, partner CROs, and regulatory vendors
• Prepare regulatory documents, Clinical Trial Application packages, and country submissions
• Prepare, manage, and track Ethics Committee submissions
• Serve as point of contact for sponsors, subcontractors, and local teams regarding study regulatory submissions
• Prepare or review Patient Information Sheets and Informed Consent Forms
• Prepare or review study-specific regulatory forms
• Manage translation requests with vendors
• Provide regulatory support, advice, submission strategies, and technical expertise to local project teams and internal/external customers
• Maintain knowledge of Health Canada, FDA, and EU regulations
• Participate in kick-off meetings, audits, and other project-related meetings

Requirements

• Bachelor's degree (or equivalent) in a scientific discipline
• Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working within Health Canada and FDA regulatory affairs and with Ethics Committee regulations
• Experience in study start-up phase
• Hands-on experience preparing, reviewing, and submitting Clinical Trial Applications and Ethics Committee packages
• Excellent knowledge of applicable regional/national regulatory guidelines and regulations
• Excellent knowledge of GCP and ICH standards
• Fluency in English with excellent oral and written skills
• Additional languages, such as French, are an asset
• Excellent organization and communication skills and attention to detail
• Ability to organize own work, prioritize assignments, and work under pressure
• Ability to multitask
• Ability to respect established timelines, expectations, priorities, and objectives
• Legally authorized to work in Canada

Core Competencies

Demonstrates expertise in regulatory compliance and clinical trial management, with a strong focus on Health Canada and FDA regulations. Proficient in preparing and reviewing Clinical Trial Applications and Ethics Committee submissions while ensuring adherence to GCP and ICH standards.

Highest-signal resume keywords

• Regulatory Compliance
• Clinical Trial Application Preparation
• Ethics Committee Submission Management
• Knowledge of GCP and ICH Standards
• Fluency in English

ATS Optimization Keywords

Hard Skills

• Clinical Research Experience
• Regulatory Document Review
• Clinical Trial Application
• Ethics Committee Regulations
• Regulatory Submission Strategies
• Patient Information Sheets Preparation
• Informed Consent Forms Review
• Study Start-Up Phase Experience
• Regulatory Guidelines Knowledge
• Multitasking

Soft Skills

• Excellent Communication Skills
• Attention to Detail
• Organizational Skills
• Ability to Work Under Pressure
• Prioritization Skills

Industry Keywords

• Health Canada
• FDA
• EU Regulations
• CRO
• Pharma
• GCP
• ICH
• Regulatory Authority
• Clinical Trial Management
• Ethics Committee