Regulatory Affairs Manager

G&L Scientific; Valencia; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Regulatory Affairs Manager to join their dynamic team. In this pivotal role, you will be responsible for developing and executing regulatory strategies to ensure product compliance with legal requirements. Your expertise will guide cross-functional teams in managing documentation and navigating regulatory landscapes. With a focus on continuous learning and a proactive approach, you'll thrive in a hybrid work environment that offers a diverse range of projects and challenges. If you're passionate about regulatory affairs and looking to make a significant impact in the pharmaceutical industry, this opportunity is for you.

Servicios

Permanent contract

Medical insurance

Disability insurance

Pension plan

Flexible remuneration

Hybrid model

Formación

• 7+ years in regulatory affairs, with experience in pharmaceutical companies.
• Strong organizational and communication skills with a proactive mindset.

Responsabilidades

• Develop and execute regulatory strategies for product registration.
• Ensure compliance with regulatory standards and manage documentation.

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 :

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.

Minimum Qualifications:

Bachelors or masters degree in health science.

Experience:

1. 7+ years in regulatory affairs, with at least 3 years of experience in pharmaceutical company.
2. Familiarity with European e-submission portals.
3. Practical experience working with different National Competent Authorities (NCAs).
4. Experience of small and large molecules, ideally across multiple therapy areas / dosage forms.
5. Working experience in writing and reviewing module 3, module 4 and module 5.
6. Experience in biological products would be a bonus.
7. Strong organizational and communication skills with the ability to manage multiple projects.
8. Proactive and team-oriented mindset with a commitment to continuous learning.
9. Excellent working knowledge of MS Office.
10. Fluent written and spoken English and Spanish.
11. High degree of attention to detail and troubleshooting skills. Analytical skills and ability to summarize.
12. Flexible and adaptable, with innovative problem-solving abilities.
13. Expert in interpreting regulatory requirements and determining compliance strategies.

Why work at G&L Scientific?

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