Principal Regulatory Affairs Specialist

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

📋 Description

• Facilitate discussions and orchestrate international regulatory strategies for assigned Phase 1–4 clinical trials, studies, and initiatives.

• Offer strategic regulatory insights, direction, and advice.

• Serve as a point of contact between internal and external stakeholders.

• Prepare and compile global regulatory submissions, including Clinical Trial Applications (CTAs).

• Engage with sponsors.

• Evaluate and review regulatory documents related to clinical trials and pertinent scientific literature.

• Manage project teams and oversee preparation activities.

• Take part in launch, review, and project team meetings.

• Participate in bid defense presentations.

• Represent the regulatory department in interactions with other departments.

• Assist in business development and regulatory initiatives.

• Contribute to quality enhancement efforts.

• Organize, lead, and report on meetings with clients and regulatory agencies.

⛳️ Requirements

• Bachelor's degree or an advanced degree preferred, or an equivalent and relevant formal academic/vocational qualification.

• Over 8 years of prior experience demonstrating comparable knowledge, skills, and abilities.

• Familiarity with the global clinical trials landscape.

• Proficient command of English, both written and spoken, and the local language where applicable.

• Experience with bid defense presentations.

• Proven track record in leading global regulatory projects for Clinical Trial Applications.

• Exceptional attention to detail, quality assurance, editing, and proofreading skills.

• Outstanding interpersonal abilities.

• Advanced proficiency in computer applications, including Microsoft Word, Excel, and PowerPoint.

• Strong organizational, time management, and planning capabilities.

• Ability to work autonomously and make independent judgments.

• Comprehensive understanding of global, regional, and national clinical trial authorization criteria and regulatory affairs procedures.

• In-depth knowledge of ICH and other international regulatory guidelines.

• Excellent analytical, investigative, and problem-solving capabilities.

🏝️ Benefits

• Award-winning learning and development program.

• Competitive salary.

• Comprehensive benefits package focused on employee health and wellness.

• Flexible work culture.

• Support for work-life balance.

• Collaborative work environment.

• Equal employment opportunity and affirmative action.