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Covering regulatory affairs, compliance documentation, product approvals, and cross-border submissions for life sciences, chemicals, and industrial products. Get fast, precise matching with vetted, available freelancers.
About the role
Regulatory scope
A regulatory consultant helps companies turn complex rules into clear action. They prepare and review submissions, assess product changes, and keep technical documentation aligned with the right legal and industry requirements. In practice, this often includes regulatory affairs work, compliance consulting, and support for product launch, market access, or change management.
- Gap analysis against current regulations and standards
- Preparation of dossiers, declarations, and supporting evidence
- Review of labels, manuals, and claims
- Coordination with internal experts, labs, and external authorities
Typical assignments
Companies bring in a regulatory consultant when a product, process, or market is moving and the internal team needs extra depth. That can be a new product launch, an update to existing compliance files, a post-audit remediation plan, or a multi-country submission with tight coordination. In Germany, this is common for firms working across local and EU requirements, where German-language documents, supplier communication, and authority-facing material must stay consistent.
- Product classification and regulatory strategy
- Submission planning and authority response support
- Policy impact assessments and implementation plans
- Update of SOPs, templates, and compliance checklists
Skills and tools
Strong regulatory consultants combine legal understanding with practical project work. They know how to read regulations, identify what matters, and translate it into documents teams can use. Familiarity with regulatory information systems, document control, version tracking, and structured review workflows is important, especially when several functions need to sign off on the same package.
They are often called regulatory affairs consultants, compliance consultants, or regulatory affairs specialists, depending on the industry. The best ones are precise, calm under pressure, and good at asking the right questions early.
- Regulatory gap analysis
- Technical writing and document review
- Risk-based decision support
- Cross-functional coordination
- Familiarity with audit and submission workflows
What strong work looks like
A good regulatory consultant does more than cite rules. They explain what the rule means for the business, what evidence is missing, and what should happen next. Deliverables are clear, traceable, and ready for internal review or external submission. They also know when to push back if a claim, label, or process is not supportable.
For companies in Germany, this matters when local teams work with international headquarters, notified bodies, or authorities. A freelance consultant is especially useful when you need focused help without building a permanent role around a short-term need.
Meet FRATCH Regulatory Consultants
Peter Herrmann
Consultant Banking Regulatory Law and Banking Reporting
Last position:
Consultant Financial Data Warehouse Migration Interfaces Reporting at Large bank / central institution
- New connection of the product interfaces of the Financial Data Warehouse (FDW) directly to the Abacus 360 native interfaces
- IT environment: PC, client-server, Citrix remote client, Oracle DB
- Mapping of FDW outbound to Abacus 360 Native
- Analysis of requirements documents, business concepts, and existing interface rules
- Definition of new FDW rules for outbound to Abacus 360
- Adjustment of test scripts for the new interfaces
- Execution of tests to ensure correct data delivery and processing
René Servos
Finance / Controlling / Regulatory Management / Optimization / Reorganization
Last position:
Freelance Interim Manager and Project Consultant at Energy Utility Company
- Analyze the existing water price calculation for formal errors and factual gaps in argumentation regarding the legal regulatory framework (including AVBWasserV, KAG RP, statutes, NEV according to BGH) and water industry best practices
- Ensuring operational controlling of the water division
- Regulatory optimization of the existing pricing strategy
- Objective assessment of existing litigation in the water sector
- Technical support to all stakeholders in the water division
- Implementation and roll-out of a new water price calculation tool
- Knowledge transfer to the controlling department and professional onboarding of new employees
- Covered vacancy by performing water price calculations
- Reviewing the pricing strategy from a regulatory perspective
- Setting up a PMO and taking on PMO tasks
- Professional advice on preparing the annual financial statements
- Expert sparring partner for the board, legal and finance/controlling in the water segment
- Optimization, adaptation and redesign of business processes in the finance/controlling environment
- Regulatory adjustments of the existing controlling
- Advising the holding's board and collaborating with subsidiaries
- Support with impairments together with auditors
- Opportunity and risk analyses for existing legal proceedings and negotiations
- Drafting price adjustment clauses and assisting in mediations
- Reorganization of equity structures
- Reporting to the head of legal, head of corporate development, and the CEO and CSO
Denys Zakhliebaiev
Technical Writer
Last position:
Technical Writer at Omilia Natural Solutions
- Creation of technical documentation for conversational AI products
- Development of user and API manuals (JSON, Markdown)
- Use of Git, Jira, Confluence for version control and task tracking
- Collaboration with engineers and PMs for accurate content
Cedric Bergermann-Bißlich
IT / Enterprise Architect (Security & Regulatory)
Last position:
Enterprise & Cloud Security Architect at ---
Enterprise & Cloud Security Architect supporting the modernization of the SDK application landscape as part of the KVNeo transformation program. Responsible for enterprise architecture, cloud governance, security architecture, and the definition of technical standards for strategic business applications.
Key responsibilities include architecture governance, target architecture development, cloud and integration architecture, security-by-design, and the translation of regulatory requirements into sustainable technical solutions across multiple business domains.
Responsibilities and achievements
- Designed and reviewed target architectures for strategic insurance applications and enterprise services.
- Developed architecture documentation based on Arc42 and Architecture Decision Records (ADRs).
- Defined governance models, architecture principles, and technical guidelines for cross-domain initiatives.
- Supported the modernization of archive, document management, and output management platforms.
- Designed integration architectures using REST APIs and event-driven communication patterns.
- Led architecture discussions with enterprise architects, development teams, product owners, and business stakeholders.
- Translated regulatory requirements such as DORA and ISO/IEC 27001 into practical architecture decisions.
- Designed security concepts covering Identity & Access Management, authorization, authentication, auditability, and logging.
- Supported SIEM integration, security monitoring, and enterprise logging concepts.
- Evaluated technical risks, technical debt, and architecture improvements while providing decision papers for architecture boards.
- Established architecture governance processes and contributed to enterprise-wide transformation initiatives.
- Supported cloud governance activities and the definition of secure cloud architecture standards.
- Facilitated architecture workshops and coordinated cross-functional stakeholders across business and IT.
Technologies & Methods Microsoft Azure • Arc42 • Architecture Decision Records (ADR) • REST APIs • Event-Driven Architecture • Microsoft Entra ID • Active Directory • IAM • SIEM • Cloud Governance • Enterprise Architecture • Security Architecture • Azure API Management • Jira • Confluence • Draw.io • DORA • ISO/IEC 27001 • Agile • Scrum
Rasika Deo
AI in Compliance - Enhanced Regulatory Reporting & Workflows
Last position:
Manuscript Consultant at R.D.V.V - Jbp
- Developed and managed content across diverse platforms, adapting tone, structure, and style to meet audience expectations and editorial standards
- Conducted in-depth research to ensure content accuracy, relevance, and alignment with client objectives and subject-matter requirements
- Edited and refined client manuscripts and drafts to improve clarity, narrative flow, coherence, and reader engagement
- Managed multiple concurrent content projects, prioritizing tasks and meeting tight deadlines while upholding high-quality standards
- Provided uncredited editing support for various publications, ensuring polished, consistent, and publication-ready final manuscripts
Dmitrii Shatov
IT Regulatory Compliance & GRC (BCM, IT Risk, DORA, ISO 22301, Outsourcing)
Last position:
IT Risk & Compliance | DORA | IT Regulatory & Operational Resilience Senior Consultant at Jefferies GmbH
Leading Jefferies’ DORA-driven operational resilience programme by strengthening ICT risk governance, control design, and regulatory readiness across key technology and outsourcing domains. Partnering with senior stakeholders to translate regulatory requirements into pragmatic governance, reporting, and assurance processes suitable for a global investment banking environment.
- Developed the Enterprise Register of Information (DORA Art. 28.3) to align with regulatory requirements.
- Defined and embedded ICT Risk Appetite and tolerance levels aligned to the Global Operational Risk Framework, strengthening decision-making and risk acceptance governance.
- Drove audit readiness by reviewing and re-drafting 50+ IT & Information Security policies, improving clarity, ownership, and control alignment.
- Oversaw the Operational Resilience Testing Programme (including penetration testing) and tracked remediation to closure, strengthening control assurance and reducing open findings.
- Aligned 10+ intra-group agreements with DORA regulatory standards.
- Enhanced executive-level decision-making with an enterprise ICT Risk Dashboard featuring KPIs/KRIs.
Sejalkumari Patel
Regulatory Documentation Specialist
Last position:
Regulatory Documentation Specialist at VRS Healthcare
- Prepared and reviewed finished product and raw material specifications as per USP, BP, EP, IP, and in-house standards.
- Developed and reviewed SOPs, analytical method validation and transfer, and comparative dissolution studies.
- Reviewed stability, DMF, and cleaning validation documents; resolved regulatory queries.
- Supported QA and RA departments to ensure compliance with GMP and site audit readiness.
Patrick Upmann
Interim Manager & Consultant for Data, AI & Regulatory Governance
Last position:
Interim Management | Consulting & Implementation | Data Deletion in SAP at BSR (Berliner Stadtreinigung)
- Topics: Business Analysis, Data Privacy, Data Management, Stakeholder Management, Conceptualization
- This project focuses on developing and implementing a strategic approach for data deletion in SAP systems. The goal is to identify the relevant data and structures during system migration to ensure both data privacy and IT system efficiency. At the same time, downtime should be minimized and regulatory requirements met.
- Development of a comprehensive approach for data deletion in SAP systems, considering data privacy and business requirements.
- Ensuring efficient and structured data transfer to the new system.
- Optimizing system efficiency and reducing downtimes during migration.
- Creating functional and technical concepts to ensure compliant and sustainable data management.
- Topic preparation: Detailed study of the "data deletion" area to lay the foundation for a structured data migration.
- Definition of project structure: Setting roles, interfaces and the project's organizational structure.
- Regulatory requirements: Analysis of data privacy regulations and business requirements to define deletion criteria.
- Approach: Developing possible scenarios and methods for data cleansing and deletion.
- Deletion concepts: Creating functional and technical deletion concepts that structure the implementation and provide clear guidelines.
- Setting deletion criteria: Defining which data and structures to delete or transfer.
- Responsibilities: Clarifying responsibilities within the project team and among stakeholders.
- Analysis of ongoing activities: Identifying and collecting existing activities in the "data deletion" area.
- Effort, cost and timeline planning: Creating estimates for resources, effort and budget.
- Implementation initiatives: Developing and executing concrete measures to apply the defined deletion strategies.
- IT system efficiency: Analyzing the existing IT infrastructure to identify optimization potential for data deletion and transfer.
- Technology trends: Evaluating new technologies and tools that can support the data cleansing process.
- Cost-benefit analysis: Assessing the financial impact of data cleansing and the introduction of new solution approaches.
- Risk management: Identifying potential risks during implementation and developing appropriate mitigation measures.
- This project lays the foundation for a sustainable and compliant data transfer to a new SAP system. With a clear approach to data deletion, it meets data privacy requirements, reduces downtimes and increases the efficiency of the new system. The results and recommendations will help companies develop a future-proof data strategy that meets legal and business needs.
Daniel Hilfer
Business Analyst, MiFID II Consultant
Last position:
Business Analyst, MiFID II Consultant at Deutsche Bank AG
- Sub-project manager and business analyst for MiFID II cost transparency
- Creating technical specifications to connect existing applications to a new MiFID II platform
- Modeling new processes in BPMN for business units
- Preparing decision templates for the steering committee
Christine Mährle
Freelance Regulatory & IT Specialist in Banking
Last position:
Management Consultant at Freelance
Conducting ICT/DORA management trainings based on DORA Article 5(4) at various banking institutions
Teaching the key elements of DORA requirements with a focus on ICT risks, third-party risk management, incident and problem management, and information registers
Deriving implementation measures and recommendations for management and business units
Praveen Kumar A
Safety Regulatory Intelligence Consultant
Last position:
Safety Regulatory Intelligence Consultant at Sanofi Aventis Deutschland GmbH
- Provide expert advice and support in the development of a software intelligence tool for monitoring worldwide legislation changes in the field of post marketing safety and regulatory activities and implementation of process workflow
- Application: Safety Regulatory Intelligence
- Activities: Requirement gathering, conceptualization of process and workflow, vendor selection, etc.
- Tools used: SharePoint, JIRA, Miro
Marcel Maurer
Quality Management Expert / Regulatory Affairs
Last position:
Quality Management Expert / Regulatory Affairs at Bereich Zahntechnik
Benoît Theunissen
Adviser – Head of Policy & Regulatory Affairs
Last position:
Adviser – Head of Policy & Regulatory Affairs at Luxembourg for Finance
- Coordinate the Working Group on Competitiveness of the Ministry of Finance
- Perform regulatory intelligence combining policy briefs and regular EU regulatory watch reports on capital markets, fintech, asset management, banking, insurance, sustainable finance, financial crime, and international sanctions
- Monitor monthly regulatory and policy developments across foreign competitive markets
- Take part in market development missions: conduct country research, company profiling, and executive biographies, identify USPs and opportunities of development
- Design the editorial content of online and hybrid events, including speaker sourcing, preparatory briefings, and panel moderation
- Provide talking points, deliver speeches, draft media Q&As and request and blog posts for strategic policy communication purposes
- Support diplomatic visits and international economic missions; gather market intelligence at industry fairs abroad and participate in policy meetings and international delegations
- Act as alternate Board Member of the Luxembourg Sustainable Finance Initiative (LSFI)
Alexander Müller
Regulatory Affairs & Cyber Security Consultant
Last position:
Regulatory Affairs & Cyber Security Consultant at Sepp.med GmbH
- Technical lead for cyber security & regulatory projects
- Preparation of environment & quality management system
- Preparation of EU (MDR) & FDA (USA) submissions
- Market and regulatory research
- Communication with Notified Bodies and authorities
- Clinical evaluation and borderline medical devices
- Cyber security: threat modeling and penetration testing
- Speaker at congresses and trade fairs
- Negotiation with customers, Notified Bodies & project participants
- Team leadership & cross-functional teamwork
Lars Koste
Temporary Head of Quality Management & Regulatory Affairs
Last position:
Temporary Head of Quality Management & Regulatory Affairs at Medical device manufacturer
- Temporary leadership of the Quality Management & Regulatory Affairs department
- Restructuring from 5 to 10+ internal and external staff
- Technical documentation
- Risk management (ISO 14971, FMEAs)
- Digitization projects
- Regulatory affairs
- Quality management
- Change management
- Clinical affairs (clinical and performance evaluations)
Discover over 15,000 top freelancers
Regulatory Consultants statistics
Aggregated from the professional profiles of matched freelancers.
Experience
16 years
Position duration
2.7 years
Positions per freelancer
10
Top business areas
Quality Assurance, Project Management, Information Technology
Top industries
Banking and Finance, Healthcare, Information Technology
Certification focus areas
Information Technology, Project Management, Quality Assurance
Bachelor's degree or higher
93%
Master's degree or higher
71%
Doctorate
14%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
94%
Daily Rate Distribution
The chart shows how the daily rates of freelancers in this role are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Average rates for Regulatory Consultants & Seniority distribution
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Frequently Asked Questions
Have questions? See our quick guide to FRATCH
A Regulatory Consultant helps a company understand what rules apply and how to meet them in practice. That can mean reviewing product files, preparing submissions, checking labels and claims, or setting up a clear compliance path for a launch or change. The role is hands-on and usually sits between legal, quality, product, and operations teams.
A freelance regulatory consultant makes sense when the need is project-based, urgent, or tied to a specific market entry or product update. It is also a good fit when your internal team lacks specialist depth in a niche area such as medical devices, chemicals, or consumer goods. You get focused support without committing to a long-term hire.
Regulatory affairs support is common in life sciences, medical technology, chemicals, consumer products, food, and industrial manufacturing. These sectors face changing requirements, product claims, and document-heavy approval work. In Germany, companies often need help aligning local practice with EU-level requirements and internal global standards.
The two titles overlap, but they are not always identical. A regulatory consultant is usually more focused on product rules, submissions, approvals, and authority-facing documentation, while a compliance consultant may work broader across policies, controls, training, and internal governance. Many freelancers cover both, especially in smaller teams.
Look for structured thinking, clear writing, and the ability to turn rules into practical next steps. A strong Regulatory Affairs Consultant should understand the relevant standards, manage documentation carefully, and communicate well with technical and non-technical teams. Industry knowledge matters too, because the right approach depends on the product and the market.
Most regulatory consulting work can be done remotely because it is document-based and communication-heavy. On-site time can help at the start of a project, during audits, or when the consultant needs to work closely with labs, quality teams, or manufacturing. In Germany, hybrid collaboration is common when several stakeholders must review the same material.
Check whether the person can explain a clear regulatory strategy, not just quote rules. Good signs are well-structured samples, a precise approach to gap analysis, and experience with the type of product or filing you need. A strong regulatory consultant should also be able to flag risks early and keep documentation consistent across versions.
A freelance regulatory consultant should be ready to map the scope, identify open gaps, and set priorities fast. Early deliverables often include a document review, a risk assessment, a submission plan, or a list of required updates for technical files and internal SOPs. Clear communication matters just as much as technical expertise.
The average hourly rate for Regulatory Consultants in Germany is 112 €, which corresponds to a daily rate of about 897 € based on an 8-hour working day.
Of the freelancers working as Regulatory Consultants in Germany, 93% hold at least a Bachelor's degree, 71% hold at least a Master's degree, and 14% hold a doctorate.
On average, freelancers working as Regulatory Consultants in Germany have 16 years of professional experience, with a single engagement typically lasting around 2.7 years.
The most common languages among freelancers working as Regulatory Consultants in Germany are German (100%), English (94%), and French (13%).
The most common industries among freelancers working as Regulatory Consultants in Germany are Banking and Finance (50%), Healthcare (44%), and Information Technology (38%).
The most common business areas among freelancers working as Regulatory Consultants in Germany are Quality Assurance (81%), Project Management (75%), and Information Technology (63%).
FRATCH Regulatory Consultants main locations
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a Free Demo
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Philipp Thomaschewski
FRATCH CEO
