Busqueda Urgente Auditoría - Seguridad Alimentaria Y Salud Ambiental (Legionella)

G&L Scientific; Comunidad Valenciana; Híbrido; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Regulatory Affairs Manager, where you will play a crucial role in ensuring compliance with regulatory requirements and managing documentation. This position offers the opportunity to work on a variety of projects, collaborating with R&D, manufacturing, and quality assurance teams. With a permanent contract and a hybrid work model, you will benefit from a comprehensive benefits package, including medical and disability insurance. If you are an experienced professional with a proactive mindset and a commitment to continuous learning, this role is perfect for you.

Servicios

Medical Insurance

Disability Insurance

Pension Plan

Flexible Remuneration

Hybrid Work Model

Formación

• 7+ years in regulatory affairs, with experience in pharmaceutical companies.
• Expertise in writing and reviewing regulatory documentation.

Responsabilidades

• Develop and execute regulatory strategies for product registration.
• Manage documentation and ensure compliance with regulatory standards.

Conocimientos

Regulatory Affairs

Communication Skills

Organizational Skills

Analytical Skills

Problem-Solving

Fluent in English

Fluent in Spanish

Educación

Bachelor's Degree in Health Science

Master's Degree in Health Science

Herramientas

MS Office

European e-submission portals

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.

Minimum Qualifications :

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 work at G&L Scientific?

• Permanent contract.
• Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
• Hybrid Model (2 days at Barcelona office).
• Wide variety of projects, new challenges and experiences.

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