Global Product Information Specialist
4 dni temu
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
- Develop and maintain primary labeling, including the CCDS, USPI, and associated patient labeling, to meet regulatory requirements and company standards.
- Ensure high-quality and compliant labeling documents, with attention to detail and a focus on accuracy.
- Collaborate with stakeholders to resolve labeling issues and implement process improvements, promoting a culture of continuous learning and improvement.
- Develop and maintain relationships with key stakeholders, including regulatory agencies and industry partners, to stay informed about emerging trends and best practices.
Requirements
- Minimum 6 years of experience in Regulatory Affairs or a related field, with a strong understanding of pharmaceutical drug development and regulatory guidelines.
- Proven track record of leading cross-functional teams and collaborating with external partners, with excellent communication and problem-solving skills.
- Advanced degree in a life science or related field, with a strong background in regulatory affairs and labeling.
- Ability to work independently with minimal supervision, with a high level of autonomy and self-motivation.
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