As a Regulatory Professional I, you will collaborate closely with the Global Regulatory Lead and a team of regulatory professionals to advance projects within the Semaglutide portfolio. Key responsibilities include:
- Supporting and providing input to all regulatory submissions to Health Authorities worldwide.
- Participating in cross-functional project teams and providing regulatory input.
- Driving, coordinating, and following up on several tasks with challenging timelines.
- Preparing and submitting documents related to the lifecycle management of marketed products (DSUR, PSUR, RMP updates, IB reviews, etc.).
- Developing regulatory documentation for Health Authorities, including clinical trial applications and marketing authorization files.
- Interacting with stakeholders across various departments to ensure alignment between local and global regulatory strategies.
- Establishing and maintaining core labeling and supporting labeling development throughout the product lifecycle.
Qualifications
- Preferred Master of Science (life sciences) relevant experience and/or PhD with 7+ years of relevant regulatory experience.
- Strong understanding of regulatory science and requirements in regions including EU, US, China, Japan, and others.
- Experience in lifecycle management, label development, EU clinical trial applications, and health authority interactions.
- Proficiency in regulatory intelligence.
- Excellent communication and presentation skills.
- Demonstrated project management skills.
- Understanding of business management and the R&D value chain in the pharmaceutical industry.
- Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.
- Knowledge of patient access and real-world evidence.
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