Regulatory Affairs Specialist

hace 2 semanas

Barcelona, Barcelona, España Galderma A tiempo completo
Job Title: Regulatory Affairs Associate

Galderma is a leading dermatology company that is committed to advancing the field through innovation and collaboration. We are seeking a highly skilled Regulatory Affairs Associate to join our team.

Job Summary:

The Regulatory Affairs Associate will be responsible for delivering innovative global regulatory strategies for clinical trial registration with health authorities. This role will involve creating and managing clinical trial regulatory strategy, executing clinical trial regulatory activities, and ensuring accurate and compliant dossiers.

Key Responsibilities:
  • Develop and implement clinical trial regulatory strategies in alignment with the global business strategy.
  • Manage clinical trial regulatory submissions, including responses to health authority queries and amendments to clinical trial dossiers.
  • Ensure compliance with regulatory requirements for pharmaceutical/biological product development.
  • Collaborate with cross-functional teams to identify and assess risks associated with clinical regulatory submissions.
  • Provide regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
Requirements:
  • Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
  • Experience with performing regulatory submissions in at least one key regulatory region.
  • Excellent communication and teamwork skills.
  • Ability to identify opportunities/major issues and to communicate impact.
What We Offer:
  • A competitive compensation package with bonus structure and extended benefit package.
  • A hybrid work culture that allows for flexibility and work-life balance.
  • Opportunities for professional development and growth within the company.
  • A diverse and inclusive work environment that values employee well-being and satisfaction.
Next Steps:
  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.

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