Regulatory Affairs Manager

### Regulatory Strategy & Decision Ownership

• Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy.
• Translate the agreed indication-level strategy into an actionable trial-level regulatory strategy and execution plan, defining regulatory pathways, priorities, deliverables, dependencies, risks, and timelines.
• Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity.
• Maintain current knowledge of applicable legislation, regulatory requirements, guidelines, and emerging regulatory developments and translate these into relevant strategic and operational guidance.
• Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements.

### Cross-Functional Leadership & Execution

• Drive the cross-functional clinical trial team to execute the agreed regulatory strategy and achieve study and program objectives, providing clear regulatory direction and ensuring timely resolution of regulatory and operational challenges.
• Partner closely with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks, and timelines into study operational plans.
• Establish clear regulatory priorities and accountabilities across the clinical trial team and proactively identify issues that could affect regulatory deliverables or study milestones.
• Lead cross-functional discussions through regulatory challenges, ensuring decisions are made at the appropriate level, documented, communicated, and translated into action.
• Escalate significant regulatory risks and strategic issues when appropriate while maintaining ownership of follow-through and resolution.
• Participate in launch meetings, project reviews, governance discussions, and project team meetings.

### Regulatory Submissions & Compliance

• Lead the development and execution of global regulatory strategies and preparation of submissions to Regulatory Authorities and Ethics Committees, ensuring high-quality standards and compliance with applicable local, regional, and global requirements.
• Provide senior review and strategic advice for regional regulatory submissions, ensuring deliverables meet or exceed applicable quality and regulatory requirements.
• Ensure regulatory deliverables are accurate, consistent, compliant, and completed within agreed timelines.
• Ensure compliance with applicable organizational and regulatory SOPs, WPDs, policies, and procedures.

### Project & Client Management

• Ensure quality performance across assigned and managed projects.
• Manage project budgets and forecasting activities.
• Identify out-of-scope activities in a timely manner and collaborate with relevant departments to support contract modifications and associated follow-through.
• Maintain effective client interfaces, providing clear recommendations, communicating risks and options, and supporting timely regulatory decisions.
• Collaborate with Business Development on pricing and new-business opportunities, including client presentations and development of proposal text, scope, and budgets.
• Provide matrix/project leadership, coaching, training, and guidance to junior team members.

## Education & Experience

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.
• Typically 9+ years of relevant experience providing the knowledge, skills, and abilities required to perform the role.
• An equivalent combination of appropriate education, training, and directly related experience may be considered.

## Knowledge, Skills & Abilities

• Excellent written and verbal English communication skills, as well as local-language capability where applicable.
• Demonstrated ability to make and own regulatory decisions, balancing regulatory requirements, strategic objectives, operational feasibility, risk, and timelines.
• Strong cross-functional leadership and influencing skills, with the ability to provide direction and drive execution in a matrix environment without relying on formal authority.
• Strong operational mindset, with demonstrated ability to translate regulatory strategy into executable plans, milestones, dependencies, and actions.
• Ability to identify regulatory and operational risks early, evaluate options, recommend a course of action, and drive issues through resolution.
• Experience with Platform Protocols and Integrated Protocol Designs highly desirable
• Exceptional interpersonal and stakeholder-management skills, including the ability to work effectively with clients, Clinical Operations, project teams, and other functional stakeholders.
• Excellent negotiation and conflict-resolution skills.
• Ability to work independently and exercise sound judgment in assessing regulatory needs and directing project teams toward compliant, pragmatic solutions.
• Excellent understanding of global, regional, and national regulatory requirements and procedures relating to clinical trial authorization, licensing, registration, and lifecycle management.
• Expert knowledge of ICH guidelines and other applicable global regulatory standards.
• Advanced expertise in one or more regulatory specialty areas, such as clinical, preclinical, CMC, publishing, or related disciplines.
• Strong 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 capabilities, including the ability to manage competing priorities and multiple complex projects.
• Excellent attention to detail, quality, editorial review, and proofreading skills.
• Excellent understanding of project budgeting and forecasting.
• Advanced proficiency with Microsoft Word, Excel, and PowerPoint and the ability to learn and adopt new technologies.

## Working Conditions & Environment

• Work is primarily performed in an office environment with standard office equipment.
• Occasional travel to site locations may be required, including domestic and international travel.
• Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.*

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Source: Statistisches Bundesamt (Destatis), table; dl-de/by-2-0; StarIn's calculation