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Regulatory and Start Up Specialist
Precision For Medicine. Deliver timely and high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws. Proficient in managing project plans and facilitating communication among cross-functional teams to ensure timely site readiness and budget negotiations.
Highest-signal resume keywords
Regulatory SubmissionsSite Activation ReadinessBudget NegotiationClinical Trial Application PreparationFluency in English and German
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ExperienceSite Start-Up ExperienceProject ManagementDocument ReviewMilestone Tracking Tools
Soft Skills
Strong Communication SkillsOrganizational Skills
Tools & Technologies
Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic MailRegulatory Intelligence Tools
Certifications & Qualifications
RAC CertificationAdvanced Degree in Medical or Life Sciences
Industry Keywords
CROPharmaceutical IndustryBiotech IndustryClinical Trial LawsInformed Consent Forms
About the role
Key responsibilities & impact- Deliver timely and high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams
- Maintain project plans, project trackers, and regulatory intelligence tools
- Support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Coordinate with assigned site CRAs to align communication and secure sites
- Review and manage essential documents required for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables
- Maintain site-level critical path data for site activation, including authority and ethics committee timelines, contracts, and budget negotiation requirements
- Support study budget negotiations and execution of investigator contracts
- Support feasibility site outreach
- Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge within PFM
- Maintain audit and inspection readiness and file documents according to TMF plans
- Support Pre-Study Site Visits when required
- Cover regulatory submissions and site contract and budget negotiation in Germany, Austria, and Switzerland
Requirements
What you’ll need- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
- At least 2 years of relevant experience
- Previous experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Experience with computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Fluency in English and German
- Qualification in Pharmacy or work experience as a Pharmacist highly beneficial
- Strong communication and organizational skills
- Relevant regulatory and site start-up experience preferred
- Experience in site contract and budget negotiation preferred
- Experience using milestone tracking tools/systems preferred
- Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred
Benefits
Comp & perks- Regular full-time employment
- Remote work arrangement
- Equal opportunity employment
- Reasonable accommodation support for applicants with disabilities