Regulatory Affairs Manager

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

📋 Description

• Take ownership of regulatory decision-making for designated clinical trials and programs.

• Convert indication-level regulatory strategies into actionable plans and execution strategies at the trial level.

• Offer strategic regulatory intelligence, guidance, and technical expertise to both internal and external stakeholders.

• Keep abreast of legislation, regulatory requirements, guidelines, and emerging developments in the regulatory landscape.

• Act as a regulatory subject-matter expert for global, regional, and country-specific requirements.

• Lead cross-functional clinical trial teams to implement regulatory strategies and meet study and program objectives.

• Collaborate with Clinical Operations and other departments to incorporate regulatory requirements, dependencies, risks, and timelines into operational plans.

• Set regulatory priorities and establish accountabilities across clinical trial teams.

• Facilitate discussions on regulatory challenges, ensuring that decisions are documented, communicated, and executed.

• Highlight significant regulatory risks and strategic issues, ensuring follow-through and resolution.

• Participate in launch meetings, project reviews, governance discussions, and project team meetings.

• Formulate global regulatory strategies and prepare submissions for Regulatory Authorities and Ethics Committees.

• Provide senior-level review and strategic advice for regional regulatory submissions.

• Ensure that regulatory deliverables are accurate, consistent, compliant, and timely.

• Maintain compliance with organizational and regulatory SOPs, WPDs, policies, and procedures.

• Guarantee quality performance across assigned and managed projects.

• Oversee project budgets and forecasting activities.

• Identify out-of-scope activities and assist with contract modifications.

• Maintain effective client interactions and support timely regulatory decisions.

• Collaborate with Business Development on pricing, new-business opportunities, client presentations, and proposals.

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

⛳️ Requirements

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

• Generally, 9+ years of relevant experience.

• A combination of appropriate education, training, and directly related experience may be evaluated.

• Exceptional written and verbal communication skills in English, with local-language proficiency where applicable.

• Capacity to make and take responsibility for regulatory decisions.

• Strong cross-functional leadership and influencing capabilities within a matrix environment.

• Operational mindset with the ability to translate regulatory strategies into executable plans.

• Skill in identifying regulatory and operational risks, evaluating options, recommending actions, and driving resolutions.

• Experience with Platform Protocols and Integrated Protocol Designs is highly desirable.

• Outstanding interpersonal and stakeholder management skills.

• Excellent negotiation and conflict resolution abilities.

• Capability to work independently and exercise sound judgment.

• Strong understanding of global, regional, and national regulatory requirements and procedures for clinical trial authorization, licensing, registration, and lifecycle management.

• Expert knowledge of ICH guidelines and other pertinent global regulatory standards.

• Advanced expertise in one or more regulatory specialty areas such as clinical, preclinical, CMC, publishing, or related fields.

• Solid understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines.

• Excellent analytical, investigative, decision-making, and problem-solving skills.

• Strong organizational, planning, and time management abilities.

• Exceptional attention to detail, quality assurance, editorial review, and proofreading capabilities.

• Proficient understanding of project budgeting and forecasting.

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

• Willingness to learn and adopt new technologies.

🏝️ Benefits

• Fully remote work setup.

• Standard Monday to Friday work schedule.

• Preferential treatment for severely disabled applicants with equivalent aptitude.

• Opportunity for occasional domestic and international travel.