Global Product Information Specialist

4 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

Role Overview

This senior manager position is responsible for overseeing 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.

Main Responsibilities

  1. Develop and maintain primary labeling, including the CCDS, USPI, and associated patient labeling, to meet regulatory requirements and company standards.
  2. Ensure high-quality and compliant labeling documents, with attention to detail and a focus on accuracy.
  3. Collaborate with stakeholders to resolve labeling issues and implement process improvements, promoting a culture of continuous learning and improvement.
  4. Develop and maintain relationships with key stakeholders, including regulatory agencies and industry partners, to stay informed about emerging trends and best practices.

Requirements

  1. Minimum 6 years of experience in Regulatory Affairs or a related field, with a strong understanding of pharmaceutical drug development and regulatory guidelines.
  2. Proven track record of leading cross-functional teams and collaborating with external partners, with excellent communication and problem-solving skills.
  3. Advanced degree in a life science or related field, with a strong background in regulatory affairs and labeling.
  4. Ability to work independently with minimal supervision, with a high level of autonomy and self-motivation.


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