REGULATORY AFFAIRS SPECIALIST

Randstad España; Barcelona; Híbrido; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company is seeking a talented RA CMC Specialist in Barcelona. The role involves supporting the development of CMCD strategies and collaborating with various departments to ensure high-quality document compilation. Candidates must have experience in QA and RA, alongside strong English skills. This hybrid position offers attractive compensation and social benefits.

Servicios

Attractive compensation package

Extensive social benefits

Flexible working conditions

Formación

• High proficiency in English is mandatory for this global position.
• Experience leading projects in QA is required.
• Experience with global markets including FDA requirements is a plus.

Responsabilidades

• Support the development of CMCD strategy for both mature and new products.
• Collaborate with R&D, Product Supply, and Regulatory for compiling quality documents.
• Address Quality questions from Regulatory Health Authorities.

Conocimientos

Proficiency in spoken and written English

Experience in QA and RA departments

Project leadership

Descripción del empleo

We're currently seeking a talented RA CMC Specialist to join an innovative big pharma company located in the metropolitan area of Barcelona within its OTC business unit

Support the development of the CMCD (Chemistry, Manufacturing, and Controls Development) strategy for certain products of the business unit, both mature and new launch, to ensure globally approvable dossiers.

• Responsibility is shared across global and local markets.
• Collaborate with R&D, Product Supply, and Regulatory to ensure the timely compilation of high-quality CTD Module 3 and QOS documents.
• Support responses to Quality questions from Regulatory Health Authorities.
• Very high proficiency in spoken and written English, as this is a global position.

Experience in QA and RA departments for global markets, including but not limited to North America, South America, Europe, Australia, ASEAN, and the Middle East.

Experience leading projects in the QA department.

Attractive compensation package with extensive social benefits.

Hybrid position with great flexibility.

You will belong to a leading big pharma company in its sector.

#Randstad promotes equal employment opportunities through diverse and inclusive teams. Randstad encourages you to reduce your environmental impact to make your environment a better place for everyone. Our commitment to the Science Based Targets (SBTi) initiative, whose targets are based on science, drives Randstad ambition to be Net Zero by 2050.