Regulatory Affairs Specialist: Strategic Growth Opportunity

hace 4 días


Barcelona, Barcelona, España Galderma A tiempo completo

Galderma, a leading dermatology company, is seeking a Regulatory Affairs Strategist to join its team in Barcelona, Spain. As a key player in the development of innovative dermatology solutions, Galderma offers a unique opportunity for growth and professional development.

About Us

With a rich legacy in dermatology and decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. Our focus on advancing dermatology for every skin story drives our passion for delivering superior outcomes in partnership with healthcare professionals.

Job Description

The Regulatory Affairs Strategist will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. This role requires collaboration with functional subject matter experts within Global R&D to ensure regulatory aspects are aligned with the global business strategy.

Key Responsibilities:
  • Developing and managing clinical trial regulatory strategy for biologics, ensuring execution in alignment with agreed clinical timelines.
  • Oversight of clinical trial regulatory submissions, guaranteeing accurate and compliant dossiers.
  • Archiving clinical trial documentation and managing health authority interaction for assigned regions.
  • Identifying and assessing risks associated with clinical regulatory submissions and recommending mitigation strategies.
  • Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
Requirements

To succeed in this role, you will need:

  • 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 skills, both written and verbal, for interfacing with regulatory agencies and senior leadership teams.
  • Demonstrated ability to work on cross-functional teams and identify opportunities/major issues.
About the Opportunity

We offer a competitive compensation package, including a salary range of €55,000 - €65,000 per year, depending on experience, as well as an extended benefit package. You will also have the opportunity to work in a hybrid work culture and participate in feedback loops to establish a personalized career path. Join our diverse and inclusive team, where everyone is empowered to grow and take ownership from day one.



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