The role of a regulatory associate plays a crucial part in the success of our products.
Job Description:
This position is accountable for operational and technical registration management processes that support the delivery of safe and effective products to patients.
Key Responsibilities:
* Provide expertise in electronic submission regulations and guidance, as well as technical content.
* Lead the registration management process by providing knowledge and understanding of local agency regulations and requirements.
* Guide and influence development teams regarding internal and Agency registration management processes and requirements.
* Ensure timely, complete, and accurate electronic records at the molecule/project level.
Requirements:
* BS or higher degree in a technical discipline such as chemistry, biology, pharmacy, or equivalent demonstrated industry experience.
* Knowledge of drug development processes.
* Previous project management and global submission experience.
* Demonstrated ability to operate and manage operational requirements in a highly regulated environment.
* Effective written, spoken, and presentation skills.
What We Offer:
A diverse and inclusive team where you can be creative, innovative, and yourself. We offer a premium workspace with flexible hybrid working options, healthcare benefits, pension and life assurance, subsidised canteen, onsite gym, travel subsidies, and on-site parking.