REGULATORY AFFAIRS (PROJECT MANAGER)

Descripción de la oferta

Pharma Industry

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.
• inglés (hablado K, escrito K)

Condiciones del puesto de trabajo

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