Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Regulatory Affairs Manager
As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
Beyond regulatory expertise, this position requires a strong operational mindset, decision-making ownership, and cross-functional leadership capability. The Regulatory Affairs Lead (RAL) will own regulatory decision-making for the assigned clinical program and drive the cross-functional clinical trial team toward execution of the regulatory strategy and achievement of program objectives.
Working closely with Clinical Operations and other key functions, the RAL will drive alignment, accountability, and execution across the clinical trial team, ensuring regulatory requirements and dependencies are understood and incorporated into operational plans. The RAL is expected not only to provide regulatory advice, but also to actively lead the team through regulatory challenges and decisions to maintain progress against agreed study milestones and strategic objectives.
What You’ll Do:
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.