Study Start Up and Regulatory Affairs Specialist

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

📋 Description

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

• Offer expert knowledge on study start-up processes and regulatory affairs.

• Guarantee regulatory compliance while collaborating with internal teams, clients, and external stakeholders.

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

• Make autonomous decisions regarding regulatory procedures and documentation strategies.

• Manage medium-complexity regulatory environments, including multi-country requirements when applicable.

• Direct study start-up and regulatory tasks for designated countries or projects, adhering to timelines, quality standards, and regulatory criteria.

• 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 documentation, and other pertinent documents.

• Provide strategic regulatory and study start-up insights to both internal and external clients.

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

• Identify and escalate risks that could threaten project deliverables while supporting corrective and preventive actions.

• Execute other job-related responsibilities as assigned.

⛳️ Requirements

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

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

• Solid knowledge of ICH GCP and national regulations pertinent to areas of expertise.

• Strong understanding of country-specific requirements for study start-up and regulatory processes across multiple countries in Europe and/or the Americas.

• Capability to lead study start-up and regulatory efforts for projects of medium complexity.

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

• Skill in drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements, and amendments.

• Familiarity with regulatory and clinical documentation, such as labels, patient information sheets, diary cards, and insurance documents.

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

• Competence in organizing and/or reviewing translations of essential documents.

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

• Ability to identify and escalate project risks while supporting corrective and preventive measures.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Join a collaborative international team.

• Opportunities for career development.

• Early career ownership and autonomy.

• Engage in meaningful clinical research that supports safe and effective pharmaceutical treatments.

• Work in a collaborative and supportive environment.