Study Start Up and Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead and orchestrate the activities necessary for achieving site initiation readiness.

• Provide expert knowledge and ensure adherence to regulatory standards.

• Act as the intermediary between internal teams, clients, and external stakeholders.

• Achieve assigned study start-up and regulatory milestones within the specified scope.

• Make independent decisions regarding regulatory processes and documentation strategies.

• Oversee study start-up and regulatory tasks for designated countries or medium-complexity projects.

• Prepare, review, and ensure quality control of regulatory and study start-up documents, including submissions, essential documents, and translations.

• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments.

• Review labels, patient information sheets, diary cards, insurance, and other documentation for compliance with ICH-GCP and country-specific regulations.

• Provide strategic regulatory and Study Start-Up guidance to both internal and external clients.

• Develop regulatory strategies, Study Start-Up Plans, joint operating procedures, and core documents.

• Identify and escalate risks that could threaten project deliverables and facilitate corrective/preventive measures.

• Perform additional work-related duties as required.

⛳️ Requirements

• A graduate degree in Chemistry or Life Sciences, Nursing, or an equivalent combination of education and experience.

• Prior experience in the pharmaceutical or CRO industry or within a regulatory agency.

• Strong knowledge of ICH GCP and national regulations relevant to areas of expertise.

• Good understanding of specific country requirements related to Study Start-Up/Regulatory delivery across multiple countries in Europe and/or the Americas.

• Capability to lead study start-up and regulatory activities for assigned countries or medium-complexity projects.

• Proficiency in preparing, reviewing, and ensuring quality control of regulatory and study start-up documentation.

• Familiarity with clinical site agreements, ancillary agreements, amendments, and country-specific regulations.

• Competence in reviewing labels, patient information sheets, diary cards, insurance, and related documentation.

• Ability to contribute to complex technical, scientific, and legal documentation.

• Skill in arranging and/or reviewing translations of essential documents.

• Ability to develop regulatory strategies, Study Start-Up Plans, joint operating procedures, and core documents.

• Aptitude for identifying and escalating project risks and supporting corrective/preventive actions.

🏝️ Benefits

• Flexible/remote work arrangements (employees have the option to work remotely).

• Emphasis on work-life balance.

• Opportunities for career advancement.

• Collaborative, international team environment.

• Trusted ownership and autonomy in your role.

• Chance to contribute to meaningful work that aids in delivering safe and effective pharmaceutical treatments to patients.