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GLOBAL REGULATORY AFFAIRS MANAGER


Solo Talento


Location

Barcelona | Spain


Job description

Position Summary
Innovative international specialty pharma Company that invests in the development of new treatments for patients through partnerships with third parties. A broad therapeutic portfolio provides help to many patients in need. Although the Company is focused on specialty medicine and the therapeutic areas of neurosciences, oncology and ophtalmology, has also a broad portfolio of products in other therapeutic areas and OTC.
As we expand our portfolio and increase our international presence, we are looking for an experienced International Portfolio Manager within the Global Regulatory Team in Headquarters located in Barcelona.
Main tasks will be related to the definition of regulatory strategy for registration of existing products in new territories and life cycle management of products at international level.
Duties and Responsibilities

• Develop and implement regulatory strategy for registration of existing products in new territories at a global level, including assessment of probability of regulatory success for a certain product.
• Establish an effective collaboration with internal commercial stakeholders and partners and ensure business needs and priorities are well understood within the International Reg Affairs Team.
• Lead International Reg Team to ensure objectives are successfully delivered on time, and with good quality standards.
• Track main regulatory activities, and monitor activities are conducted within established deadlines for any new submission, variations, deficiency letters, etc…

Número de vacantes: 1

Modalidad de trabajo: Presencial

Tipo de contrato: Indefinido


Job tags

Indefinido


Salary

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