Country Approval Specialist – German Speaking

Jobtailor; Deutschland; Remote; EUR 48.000 - 72.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a regulatory submissions specialist to prepare, review, and coordinate local submissions in line with global strategy. You will provide local regulatory strategy advice and support site start-up activities while maintaining timelines and quality across documentation.

The role requires a Bachelor's degree plus 2+ years of experience, strong English and German skills, and the ability to work in team or independently within clinical environments.

Qualifikationen

• Bachelor's degree or equivalent
• 2+ years of experience in regulatory submissions
• Equivalency may consist of education/training/experience
• Advanced level of English and German
• Excellent interpersonal skills
• Attention to detail and documentation quality
• Good negotiation skills
• Computer skills and ability to learn software
• Good English grammar skills
• Basic medical terminology knowledge
• Team or independent work capability
• Basic organizational and planning skills
• Knowledge of regional regulatory guidelines
• Office/lab/clinical environment work capability
• Ability to use PPE

Aufgaben

• Prepare, review and coordinate local regulatory submissions aligned with global strategy
• Provide local regulatory strategy advice under guidance
• Coordinate project-specific local SIA services
• Contact investigators for submission-related activities
• Serve as country-level contact for ethical or regulatory submission activities
• Coordinate with internal departments on site start-up and submission timelines
• Ensure submission processes align with site activation critical path
• Support target cycle times for site submissions
• Work with start-up CRAs to prepare regulatory review packages
• Develop country-specific patient information sheets and informed consent forms
• Assist with grant budget and payment schedule negotiations with sites
• Support feasibility activities according to timelines
• Enter and maintain trial status in PPD tracking databases
• Prepare and maintain local country study files and filing processes
• Maintain knowledge of SOPs/directives and regulatory guidelines

Jobbeschreibung

• Prepare, review and coordinate local regulatory submissions in alignment with the global submission strategy
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific local SIA services
• Contact investigators for submission-related activities as needed
• Serve as country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments on site start-up activities and submission timelines
• Ensure submission processes align with the critical path for site activation
• Achieve PPD target cycle times for sites
• Work with start-up CRAs to prepare regulatory compliance review packages as applicable
• Develop country-specific Patient Information Sheets/Informed Consent forms as needed
• Assist with grant budget and payment schedule negotiations with sites
• Support feasibility activities according to agreed timelines
• Enter and maintain trial status information in PPD tracking databases
• Prepare, set up and maintain local country study files and filing processes
• Maintain knowledge of PPD and client SOPs/directives and applicable regulatory guidelines

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency may consist of a combination of appropriate education, training and/or directly related experience
• Advanced level of English and German
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations
• Ability to work in office/laboratory and/or clinical environments
• Ability to use required personal protective equipment, including protective eyewear, garments and gloves

Core Competencies

Demonstrates expertise in local regulatory submissions and compliance, with strong capabilities in project coordination and negotiation. Proficient in maintaining documentation quality and adhering to regulatory guidelines in clinical environments.

Highest-signal resume keywords

• Regulatory Submissions
• Project Coordination
• Negotiation Skills
• Attention to Detail
• English And German Proficiency

ATS Optimization Keywords

Hard Skills

• Regulatory Compliance
• Patient Information Sheets Development
• Informed Consent Forms Preparation
• Trial Status Information Management
• Knowledge Of Medical Terminology
• SOPs And Directives Knowledge
• Submission Process Alignment
• Feasibility Activities Support
• Site Activation Processes
• Budget Negotiation

Soft Skills

• Interpersonal Skills
• Organizational Skills
• Planning Skills
• Teamwork
• Independent Work

Certifications & Qualifications

• Bachelor's Degree Or Equivalent

Industry Keywords

• Regulatory Guidelines
• Ethical Submission Activities
• Clinical Environments
• Country Regulatory Guidelines
• EC Regulations

Tools & Technologies

• PPD Tracking Databases
• Clinical Trial Management Software