Head of CMC Regulatory Affairs

Walker Cole International; Madrid; Presencial; EUR 85.000 - 120.000; Jornada completa

Descripción de la vacante

A leading specialty pharmaceutical business in Spain is seeking a Head of CMC Regulatory Affairs. The successful candidate will be responsible for developing regulatory strategies and overseeing the execution of regulatory submissions while ensuring compliance with FDA and EMA guidelines. This role requires a strong scientific background and significant industry experience.

Formación

• At least 8 years industry experience in regulatory affairs.
• Strong understanding of drug product lifecycle.
• Working knowledge of FDA, EMA, and ICH regulatory guidelines.

Responsabilidades

• Develop and create the regulatory plan, regulatory files, and tracking databases.
• Collaborate with external consultants for regulatory submissions.
• Monitor the regulatory landscape to adapt to changes affecting the business.

Conocimientos

Regulatory Affairs

Regulatory Strategy

Collaboration

Compliance Monitoring

Educación

Bachelor's degree in a scientific field

Descripción del empleo

Walker Cole International are looking for a Head of CMC Regulatory Affairs to join a leading specialty pharmaceutical business in Spain. In this role you will be responsible for the development and execution of CMC regulatory strategy for the business.

As the Head of CMC Regulatory Affairs, you will be responsible for :

• The development and creation of the Regulatory plan, regulatory files and tracking databases.
• Collaborating with external consultants and organisations to oversee the execution of regulatory submissions.
• Represent the business as Global / Regional Regulatory Lead for development programs.
• Monitoring the regulatory landscape to adapt to changes that will affect the business' portfolio.

A successful candidate will have :

• A Bachelor's degree in a scientific field with at least 8 years industry experience.
• A strong understanding of the drug product lifecycle from R&D through to marketing.
• A working knowledge of FDA, EMA and ICH regulatory guidelines.
• Extensive Module 3 experience

Regulatory Affairs | RA | Head of Regulatory Affairs| GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D

Head of CMC Regulatory Affairs • Madrid, Community of Madrid, Spain