Regulatory Affairs Specialist

il y a 2 semaines

Courbevoie, Île-de-France ProductLife Group Temps plein
About the Job

We are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will play a crucial role in the development and implementation of our regulatory strategy for oncology projects.

Responsibilities
  • Provide regulatory support for product development and registration, ensuring compliance with local and global regulations.
  • Develop and implement regulatory strategies for oncology products, collaborating with cross-functional teams to ensure effective execution.
  • Contribute to the development of global NCE/NBE development plans, ensuring alignment with regulatory requirements.
  • Prepare and review regulatory documents, including clinical study reports and responses to competent authorities.
  • Organize and manage meetings with regulatory authorities, ensuring effective communication and collaboration.
  • Participate in due diligence activities for new partnerships, providing regulatory expertise and guidance.
  • Provide advice and opinions on product candidates for licensing-in, collaborating with other departments to ensure effective evaluation.
  • Prepare regulatory analyses and contribute to the development of registration strategies for licensed-in products.
Requirements
  • Pharmacist or Master's degree in Pharmacy/Bachelor's degree in Pharmacy.
  • 5+ years of experience in Regulatory Affairs strategy/Drug development Plan, with a focus on oncology.
  • Excellent scientific writing skills and fluency in English and French.
  • Strong knowledge of RA early phase Drug development with track records in EU.
  • Team player with excellent organizational skills and ability to work independently and collaboratively.

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