Regulatory Affairs Manager – Regulatory Intelligence

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Deliver technical and project leadership across one or more regions.

• Offer expertise in regulatory affairs, client engagement, strategic regulatory intelligence, and guidance from preclinical development through to registration and product optimization.

• Generate client deliverables that comply with local, regional, and ICH regulatory and technical standards.

• Serve as a liaison with both internal and external clients in the provision and marketing of regulatory services.

• Track global regulatory changes, guidance documents, and policy trends across significant markets and stakeholders.

• Evaluate regulatory impacts on client development programs and operational practices.

• Convert regulatory findings into actionable insights and recommendations.

• Collaborate with Regulatory Affairs, Clinical, Quality, Pharmacovigilance, and Legal teams.

• Develop and distribute client newsletters, alerts, briefing documents, and selected Engage forum content.

• Conduct focused regulatory precedent searches and synthesize the findings.

• Maintain a centralized repository for regulatory intelligence.

• Engage in industry forums, working groups, and regulatory intelligence networks.

• Review and provide guidance on regional regulatory submissions.

• Offer regulatory strategy advice and technical expertise to both internal and external clients.

• Ensure quality performance for key projects and those under management.

• Oversee project budgeting and forecasting.

• Identify out-of-scope contract activities and facilitate contract modifications.

• Work closely with business development on pricing, presentations, proposals, and budgets.

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

• Ensure adherence to organizational and regulatory SOPs and WPDs.

• Participate in meetings for launches, reviews, and project teams.

⛳️ Requirements

• Bachelor’s degree or equivalent with relevant formal academic or vocational qualifications.

• Over 9 years of prior experience providing the knowledge, skills, and abilities required for the role.

• More than 5 years of specialized experience in regulatory intelligence within the biopharmaceutical sector.

• Background in CMC or a closely associated function.

• Exceptional written and oral communication skills in English, as well as the local language when applicable.

• Strong comprehension of global regulatory frameworks and the drug development lifecycle.

• Excellent analytical, writing, and presentation capabilities.

• Strong skills in project management and prioritization.

• Familiarity with regulatory intelligence tools and databases, such as Clarivate and Citeline.

• Proficiency in generative AI concepts and their application.

• Experience with agentic AI tools and workflows is highly desirable.

• Keen attention to detail, quality, editorial, and proofreading abilities.

• Exceptional interpersonal skills.

• Advanced skills in Microsoft Word, Excel, and PowerPoint.

• Strong organizational, time management, and planning skills.

• Excellent negotiation skills.

• Ability to work independently and exercise sound judgment.

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

• Expert knowledge of ICH and other international regulatory guidelines.

• Advanced understanding of regulatory specialty areas, including preclinical, clinical, CMC, or publishing.

• Comprehensive understanding of medical terminology, statistical concepts, and guidelines.

• Exceptional analytical, investigative, and problem-solving skills.

• Strong grasp of budgeting and forecasting principles.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.