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Regulatory Affairs Leader

7 dni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

About the Role

We are seeking an experienced Regulatory Labeling Senior Manager to join our team in Warsaw, Poland.

The successful candidate will be responsible for leading the development and maintenance of primary labeling for assigned compounds. This includes making recommendations on labeling content, processes, timelines, and scientific integrity. The role also involves coordinating the resolution of any labeling issues with potential impact on the primary or derived labeling.

Responsibilities

  1. Develop and maintain primary labeling for assigned compounds, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and associated patient labeling.
  2. Maintain high-quality and compliant labeling documents, ensuring they meet regulatory requirements.
  3. Collaborate with cross-functional teams to resolve labeling issues and ensure consistency across different regions.
  4. Contribute to the continuous improvement of the end-to-end labeling process, identifying areas for optimization and implementing changes as needed.

Requirements

  1. Minimum 6 years of relevant experience in the pharmaceutical industry, preferably in Regulatory Affairs or a related field.
  2. Demonstrated understanding of worldwide regulatory guidelines and their applications for guidance on labeling.
  3. Experience leading project teams within a matrix environment, combined with the ability to work independently with minimal supervision.
  4. Excellent communication and collaboration skills, with the ability to effectively communicate scientific concepts to both technical and non-technical stakeholders.

What We Offer

  1. Opportunity to join a global team and contribute to innovative projects.
  2. Option for 100% remote work within Poland, allowing for flexibility and work-life balance.
  3. Attractive salary and benefits package, including opportunities for career growth and professional development.