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Regulatory Compliance Specialist

hace 3 semanas

Logroño, La Rioja, España beBee Careers A tiempo completo
Regulatory Affairs Manager

As a key member of our team, you will play a vital role in ensuring compliance with regulatory and legal requirements. This role focuses on cross-functional activities, managing documentation and implementing strategies to support the registration of products.

Responsibilities include:

  • Developing and executing a regulatory strategy to align 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 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).

Background Requirements:

A Bachelors or masters degree in health science is required.

The ideal candidate should have:

  • At least 7 years of experience 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 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.

Key Skills and Competencies:

  • Strong organisational 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 summarise.
  • Flexible and adaptable, with innovative problem-solving abilities.

Why this Role?

  • Permanent contract.
  • Competitive salary.
  • Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
  • Flexible working schedule.
  • Wide variety of projects, new challenges and experiences.