Regulatory Affairs Officer- Maternity Cover - Milano, Italia - Recordati Group

Recordati Group
Recordati Group
Azienda verificata
Milano, Italia

4 settimane fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

The contex/Company description
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT , with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia.

An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases.

Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.


Your contribution/mission


You will report to the Regulatory Affairs Manager-International and you will be be responsible for the management of all regulatory activities related to assigned products and geographical area.


You will take care of the preparation, review and submission to regulatory authorities of all relevant documentation and management in the identified IT systems of the data and documentation to support new product registration and/or maintenance of products in the various market.


You will coordinate the preparation of discussions and negotiation with Regulatory Agencies; manage and coordinate preparation of core dossiers for corporate products; coordinate interaction with the group's affiliates, licensees and consultancy; monitor the legislation in force; define a plan and costs of the required activities.


Your profile


You have a scientific bacherlor's degree and at least 1 year experience in a similar role, preferably in CROs or pharmaceutical companies.

You are fluent in english and expert in Microsoft Office and DMS.


Additional information

Location:
Milan


Direct Manager:
Regulatory affairs manager

  • International
Fixed term contract for a maternity cover
- "At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone's contribution and achievements can be appropriately rewarded."_
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