Regulatory Labelling Specialist
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Job Summary
To support complex drug projects, the contract Associate Principal Specialist Regulatory Drug Project Delivery will provide regulatory labelling expertise, lead the development of labelling strategies, and ensure compliance with regulatory requirements while working remotely.
Key responsibilities
- Lead the development and implementation of labelling strategies for marketed and pipeline products
- Ensure high-quality Core Prescribing Information and maintain compliance with US and EU labelling regulations
- Provide regulatory labelling expertise and guidance to cross-functional teams throughout the product lifecycle
Required qualifications
- University Degree in Science or a related discipline
- 3 to 5 years of pharmaceutical experience, including regulatory experience with labelling
- Knowledge of labelling regulations and guidance
- Experience in labelling development and/or maintenance preferred
- Advanced academic training (PharmD, PhD) is highly desirable
Complete Job Description
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