Regulatory Affairs Manager

G&L Scientific; Zaragoza; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking a Regulatory Affairs Manager to oversee regulatory compliance and documentation processes. The ideal candidate will have over 7 years of experience in regulatory affairs, be fluent in English and Spanish, and possess strong organizational skills. Join G&L Scientific to work on a variety of projects that offer new challenges and experiences, all while ensuring that products comply with both national and EU regulations.

Servicios

Permanent contract

Medical insurance

Disability insurance

Pension plan

Flexible remuneration

Formación

• 7+ years in regulatory affairs, with at least 3 years in a pharmaceutical company.
• Fluent in English and Spanish, with strong communication skills.
• Experience in writing and reviewing module 3, 4 and 5 documentation.

Responsabilidades

• Developing and executing regulatory strategy for product registration.
• Managing documentation and ensuring compliance with regulations.
• Supporting various departments with regulatory queries.

Conocimientos

Strong organizational skills

Communication skills

Analytical skills

Attention to detail

Problem-solving abilities

Familiarity with European e-submission portals

Ability to manage multiple projects

Educación

Bachelors or masters degree in health science

Herramientas

MS Office

Descripción del empleo

Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team. This role focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.

Responsibilities may include :

• Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
• Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
• Working on safety, efficacy and CMC variations : variation typification and documentation preparation.
• Supporting R&D, manufacturing, quality control and quality assurance departments for potential queries.
• Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
• Planning and managing regulatory procedures on behalf of client companies.
• Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
• Managing the authorisation according to national and EU regulations (MRP, DCP and centralized procedures).
• Ensuring all project work aligns with current regulatory guidance and meets internal standards.

Bachelors or masters degree in health science.

Experience :

• 7+ years in regulatory affairs, with at least 3 years of experience in pharmaceutical company.
• Familiarity with European e-submission portals.
• Practical experience working with different National Competent Authorities (NCAs).
• Experience of small and large molecules, ideally across multiple therapy areas / dosage forms.
• Working experience in writing and reviewing module 3, module 4 and module 5.
• Experience in biological products would be a bonus.
• Strong organizational and communication skills with the ability to manage multiple projects.
• Proactive and team-oriented mindset with a commitment to continuous learning.
• Excellent working knowledge of MS Office.
• Fluent written and spoken English and Spanish.
• High degree of attention to detail and troubleshooting skills. Analytical skills and ability to summarize.
• Flexible and adaptable, with innovative problem-solving abilities.
• Expert in interpreting regulatory requirements and determining compliance strategies.

Why working at G&L Scientific?

• Permanent contract.
• Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
• Wide variety of projects, new challenges and experiences.