Senior Regulatory Affairs CMC en Michael Page

Senior Regulatory Affairs CMC
Michael Page | (9) ofertas activas
Barcelona, 10 Feb.
-
-
Descripción

Excellent opportunity to work as a Senior Regulatory Affairs CMC in a API Multinational Company within an international environment.

Detalles del cliente

API Multinational Company

Descripción de la oferta



  • Lead and coordinate regulatory activities on assigned projects and/or products world wide


  • Develop regional regulatory strategy for new products and maintenance


  • Collaborate closely with team members as well as quality, technical and commercial functions on regional and cross-regional activities


  • Ensure and maintain regulatory compliance for assigned products


  • Prepare and review regulatory documents and dossiers


  • Ensure the timely provision of high quality responses to all CMC related health authority questions


  • Interact with health authorities and customer contact persons


  • Coach and develop junior team members


Perfil del candidato



  • Master/PhD in Chemistry, Pharmacy or related discipline.


  • Minimum of 5 years regulatory affairs experience in pharmaceutical industry, CRO or health authority


  • Expert knowledge in EU regulatory affairs CMC


  • Hands-on experience and sound understanding of the regulatory processes


  • Knowledge and experience of pharmaceutical products manufacturing and analytics


  • Significant experience on regulatory CMC related regulations and guidelines for active substances


  • Fluent in English; any additional languages are a plus


  • Highly motivated and open minded personality


  • Keen to work in an international environment and to add value to the business


  • Analytical and systematic thinker, able to work well under pressure both in teams and independently to deliver on commitments


  • Good organizational skills, business orientation and flexibility


  • Excellent communication skills


Oferta de empleo


  • Valles Occidental (Barcelona) based




Numero de vacantes: 1
Tipo de contrato: Full-Time
Remuneración anual: EUR45000 - EUR55000 per annum
"
Requisitos
*Master/PhD in Chemistry, Pharmacy or related discipline.


*Minimum of 5 years regulatory affairs experience in pharmaceutical industry, CRO or health authority


*Expert knowledge in EU regulatory

Estudios mínimos
Licenciado
Experiencia mínima
5 años
Disponibilidad para viajar
El 20% del tiempo laboral

Para inscribirte a esta oferta, tendrás que acceder a la web de la siguiente empresa y cumplimentar la plantilla del curriculum. Tus datos serán almacenados en la base de datos de dicha empresa, por lo que PMFarma no se responsabiliza del uso de los mismos.


Comparte esta oferta: