REGULATORY AFFAIRS DIRECTOR

Reference Number: AL-19.038
Location: Madrid

Multinational pharmaceutical company is looking for a Regulatory Affairs Director, in the hierarchical dependency of the CEO, the main mission will be based on fostering collaboration and influence with the local Authorities (in different European countries), EMA and FDA, as well as defining the regulatory strategies necessary to obtain the approval of the products of the company for its commercialization and entry into the market. The Director will manage the team that currently makes up the Area of ​​Regulatory Affairs, composed of 9 people.

Responsibilities:

Define and implement the regulatory strategies necessary to obtain marketing authorizations for the company's research drugs. Provide regulatory advice in the stages of research and development and post authorization in order to optimize the development plans and the maintenance of the marketing authorization.

Requirements:

  • Bachelor of Health Sciences.
  • Desirable Master or Postgraduate in Regulatory Affairs and / or Market Access.
  • Proficiency in English.
  • Desirable knowledge of other European languages, preferably Spanish.
  • Minimum experience of 10 years in management positions of Regulatory Affairs in Pharmaceutical HQ.
  • Demonstrable experience in processes of registering ethical products for human use that have been successfully completed.
  • Experience and contact with local Regulatory Agencies, in the main European countries, EMA and FDA.

Competencies:

  • Strong Relational Capacity
  • Leadership
  • Customer Orientation
  • People Development