MYRIAM HAMELIN SEKAKEN

Therapeutic areas: oncology and neurology

Regions: Latin America, Middle East, Eastern Europe (Russia)

• Development and implementation of regional/global regulatory strategies across programs for biological products and small molecules.
• Submission lead for BLA, NDA and major variations (e.g CMC. new therapeutical indication) within the assigned regions.
• Meetings with Health Authorities for initial submissions and/or post approval regulatory activities.
• Compilation and monitoring of regulatory submission activities: review of regulatory documents prior to submission to ensure overall quality, completeness, and compliance.
• Coordination of resources and processes across cross-functional teams and local partners to develop and deliver complete regulatory submissions packages.
• Maximized efficiency in task completion through careful prioritization of project-related responsibilities.
• Lifecycle management.
• Products labeling review.
• GMP inspections coordination.
• Regulatory tracking tools.
• Team management.

Therapeutic areas: oncology and neurology

Regions: Latin America, Middle East, Eastern Europe (Russia)

• Development and implementation of regulatory strategies for the assigned projects.
• Lead issue resolution of regulatory risks by identifying, escalating, and monitoring issues.
• Organization of resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes.
• Contribution to the planning, execution, and assessment of product life cycle management activities and strategies.
• Coordination of the interactions and negotiations with Health Authorities.

Therapeutic area: immunology

Regions: Latin America, Asia (Hong Kong)

• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents for biotechnological products.
• Lifecycle products management for current marketed products.
• Provide regulatory input into quality management system project.
• Chair of the Americas Regulatory Forum at UCB Inc.
• GMP inspections coordination - Argentina, Mexico and Brazil.

Therapeutic area: immunology

Region: Americas (Latin America, USA and Canada)

• Regulatory submission and strategy regional lead for biotechnological products in the Americas region.
• Lifecycle products management.
• Regulatory input into clinical program development.
• Document management, databases, and tracking activities.
• Development of regulatory standards and SOPs.
• Creation and presentation of material for the Regulatory Affairs Fellowship Program.

Therapeutic areas: neurology and immunology

Regions: Latin America (Argentina, Brazil, Ecuador, Chile, Colombia, Mexico, Peru, Venezuela) and CARICAM Countries

• Regulatory liaison with the local partners across the Latin America Region.
• Lifecycle products management to support the Global Regulatory Affairs department.
• Preparation and review of packaging material and labeling.
• Review and submission of promotional materials according to local standards.
• Meeting with the Mexican Health Authority and authorized third parties.

• CMC assessment for post approval changes.
• CTD module 2 and 3 authoring for regulatory submissions.
• Regulatory data base management.
• Partnered with various departments to design and execute initiatives that support global submissions.

• Creation of regulatory affairs department.
• New drug applications for small molecules and medical devices.
• Regulatory strategies and submission plans for imported products.
• Pharmacovigilance and techno-vigilance.

• Cosmetic regulatory compliance (European Cosmetic Act).
• Risk assessments for cosmetic ingredients.
• Implementation of REACH project.