Regulatory Affairs Specialist

hace 6 días

Madrid Centro, Madrid, España Groupe ProductLife A tiempo completo
Job Description

Groupe ProductLife is seeking a highly skilled Regulatory Affairs Specialist to join our team in Spain. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to ensure compliance with national and European regulations.

Key Responsibilities
  1. Regulatory Support: Provide guidance and support to our clients regarding regulatory submissions and requests in Spain.
  2. Regulatory Activities: Contribute to the development and implementation of regulatory activities, including pre-licensing activities, new registrations, and post-approval applications.
  3. Marketing Authorization Applications: Assist with the preparation and submission of Marketing Authorization Applications (MAAs) for our clients.
  4. Post-Approval Applications: Prepare and submit documentation for post-approval applications, including Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs, and Technical/Site Transfer Applications.
  5. Regulatory Compliance: Ensure compliance with all regulatory processes, including internal and external audits.
  6. Knowledge Management: Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  7. Software Proficiency: Utilize various software packages, including Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat, to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data.
  8. Regulatory Administration: Perform general regulatory administration duties and compliance requirements.
  9. Document Management: Document and track regulatory submissions and regulatory authority approval.
  10. Data Entry: Contribute to data entry in PLG tools to enable measurements of KPI, metrics for regulatory services.
Requirements
  1. Education: At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree.
  2. Experience: At least 5 years of experience in RA in a Pharmaceutical Company or Service Provider. ES LifeCycle Maintenance (LCM) experience, ideally EU LCM experience.
  3. Skills: Hard/Technical skills, including experience in regulatory lifecycle maintenance activities for drug products, knowledge of ES regulation for pharmaceuticals, and strong computer skills.

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