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Nivel cariera

Entry (0-2 ani), Middle (2-5 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București

Acest job nu mai este activ.

As Regulatory and Medical Affairs Associate for division Healthcare 

…..you’ll be part of a multicultural team where diversity is very high both in terms of gender and in terms of nationality, where performance and achievement are the common ground to build growth.

…you’ll have responsibility for the implementation of regulatory practices across defined categories. Adhering to Global standards and local procedures, you’ll help providing safe, effective and compliant products to customers, consumers and patients, as well as accurate and consistent information to internal and external stakeholders.

 

The position will focus on:

 

  • Preparation of documentation and submission to the corresponding Authorities in compliance with current legislation to ensure efficient registration, notification and maintenance of the registrations in accordance with business strategies with the support of the Manager.
  • Represents the company in front of the National Agency for Medicines and the Ministry of Health in issues related to licensing the company’s medical products.
  • Establishing contacts with specialized companies in countries where RB products are registered, with the aim of concluding contracts of service.
  • Verifies and approves documents which are prepared within the department and registration dossiers in the country or abroad.
  • Supervises all changes that occur in the history of a product.
  • Is permanently documented regarding GMP rules, legislation regarding the registration of medicinal products in the country and region, innovations in medicine and pharmacy.

 

Requirements:

  • University Science degree in a relevant Scientific discipline (/Pharmacy or Medicine).
  • Broad knowledge of regulatory and medical affairs.
  • Minimum 1 year experience in Regulatory and Medical Affairs.
  • Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.

 

Personal Attributes:

 

  • Ability to work in an international environment
  • Result-oriented, entrepreneurial and self-motivating
  • Strong negotiating and interpersonal skills
  • Commercial understanding of operational business issues
  • Understanding of marketing strategy and planning issues
  • Ability to transform solid thinking into action
  • Openness to change and ability to think out of the box
  • Fluency in English

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