11/04/2026 updated
100 % available
Regulatory Affairs Consultant | Associate Director Level | MBA
Monaco, Monaco
Only remote
MBA, 2012 - Universidad de Navarra, SpainAbout me
Regulatory Affairs Associate Director with 20+ years in pharma, biotech and medical devices. Expert in EMA/FDA/Swissmedic CTAs/CTIS, MAAs, variations and eCTD, including combination products. MBA, Universidad de Navarra (2012).
ComplianceProduct Lifecycle ManagementLifecycle ManagementRegulatory Affairs
Global Regulatory Strategy and Lifecycle Management
Expertise in developing and executing global regulatory strategies for clinical development programmes and full product lifecycle management across EMA, FDA and Swissmedic frameworks, covering INDs, CTAs, MAAs, variations and scientific advice procedures.
Regulatory Dossier Preparation and Submission
Extensive hands-on leadership in the preparation, submission and approval of regulatory dossiers with EMA, FDA and Swissmedic, including eCTD-compliant documentation and Regulatory Information Management systems.
ICH Guidelines and Global Regulatory Frameworks
Deep knowledge of ICH guidelines and global regulatory frameworks, enabling compliant, high-quality documentation and regulatory authority interactions across multiple international markets including EU, US, Asia and Switzerland.
Regulatory Authority Interactions and Meeting Support
Direct interaction with regulatory authorities such as Swissmedic, EMA and FDA, including meeting support, response-to-questions and scientific advice procedures.
eCTD Submissions and Regulatory Information Management Systems
Maintenance of eCTD-compliant documentation standards through Regulatory Information Management systems, including migration from paper-based processes to electronic submissions.
Medical Device and Pharmaceutical Regulatory Operations
Regulatory operations experience spanning both pharmaceutical and medical device sectors, including product registrations, renewals, post-approval changes and lifecycle management across global markets.
SOP Development and Process Improvement
Development of standard operating procedures and process improvement initiatives to support regulatory compliance and operational efficiency within cross-functional teams.
Cross-functional Collaboration
Primary regulatory contact for cross-functional teams including Clinical, Quality, CMC and Development, with experience training global teams on regulatory requirements and best practices.
Submission-Readiness and Gap Assessments
Conducting submission-readiness and gap assessments for clinical-stage and approved products, including medical devices, to ensure regulatory compliance and readiness for authority review.
Expertise in developing and executing global regulatory strategies for clinical development programmes and full product lifecycle management across EMA, FDA and Swissmedic frameworks, covering INDs, CTAs, MAAs, variations and scientific advice procedures.
Regulatory Dossier Preparation and Submission
Extensive hands-on leadership in the preparation, submission and approval of regulatory dossiers with EMA, FDA and Swissmedic, including eCTD-compliant documentation and Regulatory Information Management systems.
ICH Guidelines and Global Regulatory Frameworks
Deep knowledge of ICH guidelines and global regulatory frameworks, enabling compliant, high-quality documentation and regulatory authority interactions across multiple international markets including EU, US, Asia and Switzerland.
Regulatory Authority Interactions and Meeting Support
Direct interaction with regulatory authorities such as Swissmedic, EMA and FDA, including meeting support, response-to-questions and scientific advice procedures.
eCTD Submissions and Regulatory Information Management Systems
Maintenance of eCTD-compliant documentation standards through Regulatory Information Management systems, including migration from paper-based processes to electronic submissions.
Medical Device and Pharmaceutical Regulatory Operations
Regulatory operations experience spanning both pharmaceutical and medical device sectors, including product registrations, renewals, post-approval changes and lifecycle management across global markets.
SOP Development and Process Improvement
Development of standard operating procedures and process improvement initiatives to support regulatory compliance and operational efficiency within cross-functional teams.
Cross-functional Collaboration
Primary regulatory contact for cross-functional teams including Clinical, Quality, CMC and Development, with experience training global teams on regulatory requirements and best practices.
Submission-Readiness and Gap Assessments
Conducting submission-readiness and gap assessments for clinical-stage and approved products, including medical devices, to ensure regulatory compliance and readiness for authority review.
Experience
Professional experience10+ years
Freelancer since2026
Languages
GermanFluentEnglishNative speakerFrenchGoodSpanishNative speaker
Project history
Regulatory strategy and hands-on submission support for sponsors and development teams: CTAs, MAAs, variations, scientific advice and lifecycle maintenance across EMA, FDA and Swissmedic frameworks. Submission-readiness and gap assessments, response-to-questions support, and regulatory intelligence for clinical-stage and approved products, including medical devices.
Developed and contributed to regulatory strategies supporting clinical development programmes and product lifecycle management across Switzerland for a global CRO. Led the preparation, submission and approval of regulatory dossiers (CTAs) with Swissmedic and Ethics Committees, serving as single point of contact and Swiss legal representative for all submissions and communications. Key regulatory contact for international project teams and clients; interacted directly with Swissmedic and trained global teams on Swiss CTA requirements and lifecycle best practices. Maintained eCTD-compliant documentation standards through Regulatory Information Management systems; received the PPD Exceptional Performance Award (Feb 2018).
Developed global regulatory strategies for product registrations, renewals and lifecycle management across EU (EMA), US (FDA), Asia and Swiss markets. Led preparation, submission and approval of regulatory dossiers, variations and post-approval changes; managed a cross-functional team of regulatory professionals. Led the successful rollout of a new Regulatory Information Management system, including migration from paper-based processes, directly supporting eCTD submissions.