Regulatory Affairs Manager

G&L Scientific; Almería; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Join a leading company as a Regulatory Affairs Manager where you'll manage regulatory strategies and compliance. Ideal candidates will have significant experience in regulatory affairs, a strong educational background in health sciences, and bilingual proficiency in English and Spanish. Your role will involve cross-functional collaboration and ensuring adherence to regulatory standards.

Servicios

Permanent contract

Benefits package (medical insurance, disability insurance, pension plan, and flexible remuneration)

Variety of projects and challenges

Formación

• 7+ years in regulatory affairs, with 3 years in a pharmaceutical company.
• Experience with European e-submission portals and NCAs.
• Fluent in English and Spanish.

Responsabilidades

• Developing regulatory strategies for product registration.
• Preparing CMC documentation and managing regulatory compliance.
• Submitting documentation to authorities and ensuring ongoing product compliance.

Conocimientos

Organizational skills

Communication skills

Analytical skills

Problem-solving

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.

J-18808-Ljbffr