Regulatory Affairs Manager

G&L Scientific; Barcelona; Presencial; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Regulatory Affairs Manager, where you'll play a crucial role in ensuring compliance with regulatory standards. This position offers the opportunity to develop and execute regulatory strategies, manage documentation, and support various departments in a dynamic environment. With a focus on continuous learning and a proactive mindset, you will be instrumental in navigating the complexities of regulatory affairs. Enjoy a hybrid work model and a comprehensive benefits package while tackling diverse projects that challenge and inspire you.

Servicios

Medical Insurance

Disability Insurance

Pension Plan

Flexible Remuneration

Hybrid Work Model

Formación

• 7+ years in regulatory affairs, with 3 years in a pharmaceutical company.
• Experience in writing and reviewing modules 3, 4, and 5.

Responsabilidades

• Develop regulatory strategies for product registration.
• Prepare and analyze CMC documentation for compliance.

Conocimientos

Regulatory Affairs

Communication Skills

Organizational Skills

Analytical Skills

Problem-Solving

Attention to Detail

Fluent in English

Fluent in Spanish

Educación

Bachelor's Degree in Health Science

Master's Degree in Health Science

Herramientas

MS Office

Descripción del empleo

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Direct message the job poster from G&L Scientific

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

Responsibilities may include:

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

Bachelor's or master's degree in health science.

Experience:

• 7+ years in regulatory affairs, with at least 3 years of experience in a pharmaceutical company.
• Familiarity with European e-submission portals.
• Practical experience working with different National Competent Authorities (NCAs).
• Experience with small and large molecules, ideally across multiple therapy areas/dosage forms.
• Experience in writing and reviewing modules 3, 4, and 5.
• Experience with 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 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.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Science, Health and Human Services