Regulatory Submissions Manager II

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

📋 Description

• Take charge of and oversee submissions to Regulatory Authorities (RA), Institutional Review Boards/Ethics Committees (IRB/EC), and Third Bodies for designated clinical trials.

• Formulate submission strategies, manage planning, and oversee timelines.

• Monitor approvals in relation to project milestones (GL, RTE).

• Coordinate responses to inquiries from regulatory authorities within specified timelines.

• Lead or assist with European Clinical Trial Regulation (EU CTR) submissions through the Clinical Trials Information System (CTIS).

• Prepare, submit, and maintain applications within the CTIS framework.

• Manage user access for CTIS and serve as a backup when necessary.

• Provide guidance to internal teams regarding CTR/CTIS processes and expectations.

• Prepare, review, and ensure quality of core and country-specific regulatory submission packages.

• Ensure that deliverables adhere to relevant regulations, guidance, standard operating procedures (SOPs), and client requirements.

• Offer regulatory guidance by keeping current with global and EU regulatory standards.

• Collaborate or assist local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies.

• Identify and proactively raise concerns regarding potential risks to timelines, quality, or approvals.

• Assist with audits, inspections, and the resolution of findings.

• Contribute to initiatives aimed at process improvement, including the development and optimization of SOPs.

• Mentor junior colleagues and aid in building team capabilities.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related discipline (or equivalent experience).

• At least 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start-Up within the pharmaceutical, biotechnology, or CRO sectors.

• Practical experience with EU CTR and CTIS is essential.

• Proficient in preparing and submitting applications within the CTIS.

• Experience in managing CTIS workflows, timelines, and user access.

• Background in addressing CTIS-related inquiries from authorities.

• Strong understanding of the RA, IRB/EC, and Third Body submission processes.

• Experience in supporting global or regional clinical trials.

• Excellent organizational skills with the capacity to manage multiple submissions and deadlines.

• Effective communication skills and the ability to collaborate with cross-functional teams and client stakeholders.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and continuing education.

• Flexible work schedules and remote work options.

• A supportive and inclusive work environment.