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Senior Regulatory Compliance Specialist

hace 3 semanas

Torrejón de Ardoz, Madrid, España beBee Careers A tiempo completo
Regulatory Affairs Manager Job Description

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Overview:

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We are seeking an experienced Regulatory Affairs professional to play a vital role in our team. This position focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.

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Responsibilities:

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  • 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.
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Requirements:

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We require a Bachelors or masters degree in health science.

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Experience:

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  • 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.
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Skills and Qualifications:

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  • 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.
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Benefits

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  • 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.
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Why this job?

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This is an exciting opportunity to work in a dynamic environment and develop your skills and expertise as a Regulatory Affairs professional.