Principal Regulatory Affairs Professional

This is a fully remote position, open to applicants in Chile, +5 more countries.

📋 Description

• Deliver strategic regulatory intelligence and guidance to support product development from preclinical phases through to registration and product optimization.

• Create client deliverables that align with local, regional, and ICH regulatory and technical standards.

• Serve as a liaison between internal and external clients in the delivery and promotion of regulatory services.

• Evaluate regulatory documents and submissions to ensure they meet high quality standards and comply with client, local, and regional requirements.

• Counsel internal and external clients on regulatory strategies while providing current legislation and guidance.

• Engage in project management activities that support regulatory services.

• Offer matrix/project leadership, training, and mentorship to junior team members.

• Contribute feedback on performance evaluations to management.

• Ensure compliance with project budgets, timelines, scope of work, organizational and regulatory SOPs, and WPDs.

• Participate in business development initiatives, including project budgeting and forecasting.

• Occasionally travel to site locations domestically and internationally.

⛳️ Requirements

• A Bachelor's degree or an equivalent relevant formal academic/vocational qualification.

• Over 8 years of prior experience providing the knowledge, skills, and abilities necessary for the role.

• A combination of appropriate education, training, and/or directly related experience may be deemed sufficient.

• Exceptional written and oral communication skills in English, along with proficiency in the local language where applicable.

• Strong attention to detail, with excellent quality, editorial, and proofreading skills.

• Well-developed interpersonal, organizational, time management, planning, negotiation, analytical, investigative, problem-solving, and independent judgment skills.

• Proficient computer skills, including Microsoft Word, Excel, and PowerPoint, and the ability to adapt to new technologies.

• Capability to manage multiple projects, shifting priorities, timelines, budgets, and forecasts.

• Solid understanding of global, regional, and national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.

• Expert knowledge of ICH and other global regulatory guidelines.

• Good comprehension of regulatory specialty areas such as preclinical, clinical, CMC, and publishing.

• Strong grasp of medical terminology, statistical concepts, and guidelines.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.