Senior Regulatory Affairs CMC en Michael Page

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

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
*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
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.

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