Clam Emna

• • Led cross-functional regulatory and strategic projects supporting global portfolios, market access, lifecycle management and post-approval activities.

• • Acted as strategic partner to senior stakeholders, translating business priorities into clear, executable project plans, timelines and deliverables.

• • Oversaw end-to-end execution of regulatory and lifecycle initiatives, including planning, coordination, risk management and progress tracking across a large volume of submissions.

• • Supported portfolio alignment and process improvements by strengthening coordination between Regulatory, Medical, Pharmacovigilance, Quality, Supply, IT and Commercial teams.

• • Managed and coordinated global, multicultural teams and external partners, ensuring efficient use of resources, timely delivery and compliance with regulatory requirements.

• • Contributed to the implementation and improvement of regulatory systems and data tools (QMS, RIM, tracking dashboards) to enhance visibility, consistency and decision-making.

• • Helped define governance, reporting and performance indicators to improve predictability, compliance and delivery quality.

• • Ensured all activities were conducted in accordance with internal procedures and applicable regulations, supporting ongoing inspection readiness.

• • Supported medical and regulatory teams by ensuring availability, accuracy, and consistency of scientific and regulatory information used in lifecycle management, and medical communication activities.

• • Supported the preparation and review of scientific materials for publications and congress communications, ensuring accuracy, consistency, and compliance with medical, scientific, and regulatory standards.

• • Led cross-functional projects involving Medical Affairs, Regulatory, and IT, ensuring alignment between medical strategy, regulatory requirements, and operational execution.

• • Contributed to clinical and post-marketing activities by coordinating submission planning, lifecycle updates, and regulatory commitments in line with evolving scientific data.

• • Developed and standardized best practices, templates, and guidance to support compliant scientific documentation and consistent medical information across portfolios.

• • Supported medical and scientific teams by ensuring high-quality regulatory and product data underpinning safety activities, and medical communication.

• • Contributed to real-world data readiness and evidence governance, supporting accuracy and traceability of product and safety data across 90+ countries.

• • Collaborated with Medical Affairs, Pharmacovigilance, and Regulatory to ensure consistency of scientific information used for regulatory submissions, safety reporting, and medical responses.

• • Participated in cross-functional governance initiatives, clarifying roles and responsibilities for scientific and regulatory data ownership.