mélanie julien

executive director, sales and administration

About

I have always been attracted to science, especially Biology and its medical applications. My family background has helped me foster an entrepreneurial mind-set, with parents owing a local wine trade. As such I deeply admire creative and innovative people. MedinCell’s entrepreneurial culture fits with my personal and professional values, and has allowed me to grow as an individual and as a manager. My role as Head of Operations is deeply hands on and solution-driven, working on continuous improvement of our processes and adapting roles to support strategic decisions.

Country

france

City

montpellier

Industry

wine and spirits

Skill

regulatory affairs, quality, regulatory strategy, english, pharmaceuticals, drug delivery, quality system, pharmaceutical industry, long acting depot, life sciences, controlled release, security systems integration, health and safety, biotechnology, development strategy, project management, regulatory documentation, operations management, project planning, parenteral formulation, injectable, software project management, change management, team management, organizational structure, organizational management, fda, toxicology, sop, regulatory agencies, research, glp, gmp, non clinical, cro, ema, merlin, strategy, process improvement, start ups, strategic planning, entrepreneurship, continuous improvement, organizational leadership, pre clinical management, operational transformation

Experience

head of operations

medincell

2015-5 - 2019-10 · 4 yrs 6 mos

This new step in my carrier is the opportunity for me to support the operational transformation occurring at MedinCell, with the need for a refocusing of the teams around product development. Since 2013, I led 4 major organizational transformations of the R&D department. My role is to manage strategic projects, be they related to organizational change or pre-clinical development. This diversified mission leads me to interact with several areas of expertise at MedinCell, from pre-clinical research, to regulatory and quality affairs, and to lead cross functional project teams. My direct reports range from the QEHS unit to General Services and IT/Digitalization, My involvement led to significant achievements, including strong productivity improvements, reduction of development timelines, increased success rate of projects and partnering up with top 5 generic pharmaceuticals companies.

executive director, sales and administration

transvins

2019-10 - Present · 7 yrs

preclinical manager and operations specialist

medincell

2014-3 - 2015-5 · 1 yr 3 mos

* Participate to the complete restructure of the company: establishment of the development department (way of working, team constitution, department resources management, etc) * Coordinate all development projects * Collaborate with and coordinate activities of multiple departments * Development project selection committee core member * Provide preclinical expertise and strategy to multi-functional project teams in collaboration with recognized experts * Coordination and management for non-clinical studies, incorporating strategy, outsourcing and monitoring * Management of transversal projects * Communication with external clients and internal staff * Develop of multicounty regulatory strategy (mainly US and EU) and update strategy based upon regulatory changes * Plan, schedule and direct regulatory activities and programs * Attend meetings with regulatory authorities

quality and regulatory affairs specialist

medincell

2011-9 - 2014-3 · 2 yrs 7 mos

* Support management in the implementation of the quality policy * Generate SOPs * Develop, coordinate and improve the realization of the quality policy * Control and improve the quality documentation system * Legal watch * Provide strategic guidance for product development and planning throughout the product lifecycle * Develop & maintain regulatory knowledge of EU & US regulations * Develop global regulatory strategies and update based upon regulatory changes * Provide strategic input and technical guidance on regulatory requirements to development teams * Collect information on registration instructions and regulations * Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed. * Interact with regulatory authorities (US / EU) * Train staff in regulatory policies or procedures.

regulatory affairs intern

medincell

2011-3 - 2011-9 · 7 mos

* Regulatory intelligence for human and veterinary product * Toxicology bibliographical research * Redaction (with a team) of the “Document Unique” * Prepared and coordinated EMEA and FDA scientific advices * Provide regulatory support to project investigators and business developers