Feina Activa
ca

REGULATORY AFFAIRS (PROJECT MANAGER)

2 Inscritos

Oferta personas con discapacidad

Referencia oferta:

FA06086714

Fecha publicación oferta:

24/04/2025

Puestos de trabajo:

1

Consultora de Talento

Descripción de la oferta

Pharma Industry

BARCELONA - BAIX LLOBREGAT - 08840 VILADECANS

Detalle de las funciones del puesto de trabajo

• Reviewing Marketing Authorization Application (MAA) dossiers and liaising with the RA department at the company’s headquarters in India. • Supporting existing and potential clients with regulatory/technical information about company products. • Preparing and submitting dossiers to health authorities in EU countries using national and decentralized procedures. • Contacting European health authorities to follow up on submissions. • Communicating with European customers to develop RA strategies and coordinate submissions. • Reviewing and submitting response documents to deficiency letters from health authorities. • eCTD publishing. • Ensuring proper maintenance of dossiers, including PSUR submissions, variations, and renewals. • Keeping up to date with the latest regulatory requirements in the region. • Performing selected pharmacovigilance activities. • Providing support for the development of quality agreements and product release. • Proposing, developing, and implementing new standard operating procedures.

Requisitos

  • Experiencia 3 años. The profile • valuable education to a degree level in pharmacy or a life science. • 3 to 5 years of experience in the regulatory affairs department of a pharmaceutical company, preferably with generic medicinal products. • experience with european ma procedures (dcps) will be an asset. • experience with procedures in european non-eu countries, such as israel, serbia, and canada, will be an asset. • experience with pharmacovigilance and quality assurance will be an asset. • experience with ectd software will be an asset. • good knowledge of current european regulations on the registration of medicinal products. Knowledge of gmp and pharmacovigilance is a plus. • fluency in english, both written and spoken. Computer skills at a user level.
  • Título de grado
  • Bachelor's degree in pharmacy or related fields.
  • Inglés (hablado c1 - d.funcional, escrito c1 - d.funcional)

Condiciones del puesto de trabajo

  • Contrato laboral indefinido
  • Jornada completa
  • Salario mensual bruto desde '2000' hasta '3000'
  • Otros datos de interés: flexible working hours