Labeling Expert Senior Manager

4 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

Job Summary

This is a senior leadership position that oversees the development and maintenance of primary labeling for pharmaceutical products. The successful candidate will lead cross-functional teams and collaborate with external partners to ensure compliance with regulatory requirements.

Key Responsibilities

  1. Lead the development and maintenance of primary labeling, including the CCDS, USPI, and associated patient labeling.
  2. Ensure high-quality and compliant labeling documents, meeting regulatory requirements and company standards.
  3. Collaborate with stakeholders to resolve labeling issues and implement process improvements.
  4. Develop and maintain relationships with key stakeholders, including regulatory agencies and industry partners.

Requirements

  1. Minimum 6 years of experience in Regulatory Affairs or a related field, with a strong understanding of pharmaceutical drug development.
  2. Proven track record of leading cross-functional teams and collaborating with external partners.
  3. Excellent communication and problem-solving skills, with the ability to navigate complex regulatory environments.
  4. Bachelor's degree in a life science or related field, with advanced degrees preferred.


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