Netherlands
Senior Regulatory Affairs professional with over 20 years of experience, including leadership roles within multi-country organizations across Europe and international markets. Proven track record in driving organizational and product portfolio restructuring. Empathetic leader passionate about developing people and empowering them to achieve their best. Advocate of cross-functional collaboration and operational efficiency, with a strong focus on results and business outcomes.
Lead operational and strategic RA activities in the Emerging Market territory covering Middle-East North Africa and Sub-Sahara Africa (MENASSA), Russia-CIS, South Africa, and Turkey.
Management of the team overseeing regulatory, pharmacovigilance and quality activities for the distributor markets in Malta, Middle-East, North-Africa and Sub-Saharan Africa.
Management of the regulatory team responsible for the registration procedures of the pharmaceutical products in Malta, Middle-East, North Africa, and Sub-Saharan Africa.
- In charge of proposing and implementing the registration strategy for the development and maintenance of a product portfolio (endocrinology therapeutic area); - Coordination of regulatory activities related to the products Marketing Authorisations Life Cycle Management (National procedure and Mutual Recognition Procedure) : preparation of clinical and pharmaceutical variation dossiers, Clinical Trial Authorizations Applications, renewals, update of the product Core Safety Information; - Support of Group subsidiaries in their registrations : sending of the dossiers, management of responses to Authorities questions, tracking of the regulatory submissions.