Regulatory Affairs Technician pharma - Viladecans, España - Hetero Europe

Descripción

Pharmaceutical Industry

Regulatory Affairs Technician / Job Description

Company description:

Hetero Europe is a generic pharmaceutical company, founded in 2010 and based in Barcelona, as a B2B subsidiary of Hetero, a global pharmaceutical company headquartered in Hyderabad, India.

We specialize in supplying high-quality generic pharmaceutical products to our European clients, as well as providing IP/Regulatory support, embraced by our comprehensive and continuously growing product portfolio of over 200 products of finished dosage forms of oral solids, liquids, and injectables.

Industry:
Pharmaceutical


Position:
Regulatory Affairs Technician


Experience:
mid-junior level


Job Function:
Regulatory


Employment type:
Full-Time


Location:
Viladecans Business Park Viladecans (Barcelona)


Job description:

Hetero Europe is looking for a dynamic and experienced Regulatory Affairs professional to support the activities of the team. Incorporation is foreseen in Q3 2023.


Key responsibilities and accountabilities:

• Reviewing Marketing Application Authorization (MAA) dossiers and liaising with the RA department at the company Headquarters in India.
• Supporting existing and potential clients with regulatory/technical information on Hetero ́s 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.
• Reviewing and submitting response documents to deficiency letters of Health Authorities.
• Managing the national phase of the finalized procedures.
• Ensuring adequate maintenance of the dossiers: PSUR submissions, variations, renewals...
• Keeping up to date with the latest regulatory requirements in the region.
• Performing selected pharmacovigilance activities.
• Providing support for the elaboration of quality agreements and for product release.
• Proposing, elaborating and implementing new standard operation procedures.

Desired Skills and Expertise:

• Education to a degree level in Pharmacy or a life science
• At least 2 years' experience in the Regulatory Affairs Department of a pharmaceutical company, preferably with generic medicinal products.
• Experience with European MA procedures (DCPs) will be valued.
• Experience with procedures in European Non-EU countries and Israel will be valued.
• Experience with Pharmacovigilance and Quality Assurance will be valued.
• 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 user's level.
• Effective teamwork, excellent communication skills, and good organization skills; a flexible and enthusiastic approach to work, using your knowledge to solve technical issues, a customerfriendly attitude, and the ability to work with demanding time frames.

What we offer:

• Contract of Employment: permanent position
• Benefits package: health insurance, ticket restaurant.
• Hybrid work model: One day per week for remote work, and as needed for specific circumstances.
• Flexible schedule.
• Good work atmosphere and interaction within a multicultural team.

If of interest, please submit your CV in English and specify salary expectations and availability to start.


Tipo de puesto:
Jornada completa

Salario: 30.000,00€-40.000,00€ al año


Beneficios:

• Ayuda al desarrollo profesional
• Eventos de la empresa
• Flexibilidad horaria
• Jornada intensiva los viernes
• Seguro médico privado
• Ticket restaurante

Horario:

• De lunes a viernes
• Flexibilidad horaria

Preguntas para la solicitud:

• Do you currently hold a valid work permit for Spain?
• Are you capable of commuting to the office in Viladecans, Barcelona, Spain?

Idioma:

• Inglés
• Competencia profesional (Obligatorio)

Ubicación del trabajo:
Teletrabajo híbrido en 08840 Viladecans