Study Start Up and Regulatory Affairs Specialist

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

📋 Description

• Oversee and coordinate the necessary activities to ensure readiness for site initiation.

• Offer subject matter expertise while maintaining regulatory compliance.

• Act as a liaison between internal teams, clients, and external stakeholders.

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

• Make independent decisions regarding regulatory processes and documentation strategies.

• Lead study start-up and regulatory efforts for designated countries or medium-complexity projects.

• Prepare, review, and conduct quality control on regulatory and study start-up documentation, which includes submissions, essential documents, and translations.

• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at the country or regional level.

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

• Contribute to the creation of complex technical, scientific, and legal documentation.

• Organize and/or review translations of essential documents.

• Provide strategic input on regulatory and study start-up matters.

• Develop regulatory strategies, study start-up plans, joint operating procedures, and core documents.

• Identify and escalate project risks, providing support for corrective and preventive actions.

• Undertake other work-related duties as assigned.

⛳️ 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 in a regulatory agency.

• Solid understanding of ICH GCP and national regulations relevant to the areas of expertise.

• Strong comprehension of country-specific requirements related to study start-up and regulatory delivery across multiple countries in Europe and/or the Americas.

• Experience managing medium-complexity regulatory environments and multi-country requirements where applicable.

🏝️ Benefits

• Remote work options available.

• Emphasis on work-life balance.

• A collaborative, international team environment.

• Opportunities for career advancement.

• Trusted ownership and flexibility in your role.

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

• A dedicated and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.