Regulatory Affairs Manager (Maternity Leave 6 to 8 months) Madrid

Descripción de la oferta

Duración de la oferta: hasta el 28/09/2018.

Funciones

Supports the activities of the affiliate's Regulatory Affairs team with local Regulatory Authorities and other stakeholders to ensure that the company complies with country's/ies applicable legislation and regulations pertaining to our portfolio.


Description

* Support the interaction and communication with the local Health Authorities (HA)
 * Works proactively to build and maintain contacts with relevant local HA personnel at own level.
 * Support interactions with other departments/functions for response to local HAs.
 * Support for incidents involving regulatory matters (as required).
 * Support the management of relevant local HA inspections.
 * Prepare regulatory (submission) documentation with direct supervision from more senior associates regarding Healthcare Provider Communications submissions and follow-up and Risk Minimization Measures submissions and follow-up until approval.
 * Prepares regulatory submission documentation with direct supervision from more senior regulatory personnel in order that all regulatory submissions to local HAs are done in line with local HA expectations, Companies SOP's and business objectives for assigned product(s) or projects.
 * Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in the Company.
 * Knowledge of the main sources of Regulatory intelligence and the Affiliate role in rapidly screening and communicating changes to regulatory information to International Regulatory, Regulatory Intelligence and the local Affiliate.
 * Monitor competitor regulatory information such as approvals, changes in label and other relevant local details.


Profile

* Typically requires a degree in a scientific field and relevant experience in regulatory affairs.
 * Experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Bio tech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local territory is preferred.
 * Excellent organization skills and ability to work on a number of projects with tight time lines is required.
 * Excellent verbal and written communication skills and interpersonal skills are required.
 * Good knowledge of regulatory systems is required.
 * Very good verbal and written English is required.


Job Offer

Opportunity to join one of the most important companies in the world in the bio-pharmaceutical industry, and share your experience in one of the most innovative entities for a while.

Requisitos

Supports the activities of the affiliate's Regulatory Affairs team with local Regulatory Authorities and stakeholders to ensure the company complies with country's/ies applicable legislation.

Se ofrece

Meal vouchers and Medical Insurance