Senior Regulatory Affairs Specialist

hace 7 días


Barcelona, Barcelona, España Westerman A tiempo completo

Westerman is a top firm specializing in high-value intelligent solutions in executive search. Our approach combines the boutique model of international headhunting with a strong digital strategy based on e-searching.

We are partnering with a leading company in the pharmaceutical sector with a global presence to fill the role of EMEA Regulatory Affairs Specialist.

The key responsibilities for this position include:

  • Ensure compliance with regulatory, pharmacovigilance, and quality standards in Europe
  • Develop and execute Regulatory submission strategies in Europe, particularly focusing on B2C activities
  • Support product submissions in Europe, especially via DCP, and manage national phase coordination
  • Assist in maintaining granted marketing authorizations and coordinating variations
  • Collaborate with Global RA, QA, and Pharmacovigilance teams
  • Support BD function and address Technical Issues with Customers
  • Assist the Qualified Person for Pharmacovigilance and manage European pharmacovigilance system
  • Support QA-related activities in Europe
  • Manage method transfer and batch release process in Europe
  • Liaise with European Health Authorities
  • Represent the company during client interactions
  • Recommend and implement new operating procedures
  • Stay updated on EU legislative guidelines

Requirements:

  • Minimum 5 years of experience in Regulatory Affairs with EU procedures exposure
  • Science Degree, preferably post-graduate Master in Industrial pharmacy
  • Strong written and verbal communication skills in English and Spanish, additional European language is a bonus
  • Proficient in Word, Excel, and Outlook
  • Ability to manage complex projects and multitask
  • Excellent organizational skills
  • Proactive, adaptable, and confident working independently
  • Proficient in computer use
  • Professional, punctual, and team-oriented

Benefits:

  • Opportunity to be part of the exciting expansion project of a global pharmaceutical company
  • Develop a European-wide profile collaborating with international company departments
  • Competitive salary
  • Hybrid and flexible work setup


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