Regulatory Affairs Manager

G&L Scientific; Madrid; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking an experienced Regulatory Affairs Manager to join their dynamic team. In this pivotal role, you will develop and execute regulatory strategies while ensuring compliance with legal requirements. You'll collaborate with various departments to manage documentation and navigate complex regulatory landscapes. This position offers a permanent contract with a competitive salary and a comprehensive benefits package, including medical and disability insurance, a pension plan, and a flexible working schedule. Join a forward-thinking company that values innovation and continuous learning, and take on new challenges across a wide variety of projects.

Servicios

Medical Insurance

Disability Insurance

Pension Plan

Flexible Remuneration

Flexible Working Schedule

Formación

• 7+ years in regulatory affairs, with 3+ years in a pharmaceutical company.
• Experience with national and EU regulations, including MRP and DCP.

Responsabilidades

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

Conocimientos

Organizational Skills

Communication Skills

MS Office

Fluent English

Fluent Spanish

Analytical Skills

Problem-Solving

Regulatory Compliance Interpretation

Educación

Bachelor's in Health Science

Master's in Health Science

Herramientas

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:

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 the 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 the authorisation 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.

Background:

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.

Skills & Competencies:

1. Strong organizational and communication skills with the ability to manage multiple projects.
2. Proactive and team-oriented mindset with a commitment to continuous learning.
3. Excellent working knowledge of MS Office.
4. Fluent written and spoken English and Spanish.
5. High degree of attention to detail and troubleshooting skills.
6. Analytical skills and ability to summarize.
7. Flexible and adaptable, with innovative problem-solving abilities.
8. Expert in interpreting regulatory requirements and determining compliance strategies.

Why work at G&L Scientific?

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