This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Deliver regulatory CMC consulting for small molecule products utilizing Veeva RIM.

• Evaluate and comprehend regulatory guidelines.

• Understand and assist with the requirements and processes necessary to keep products in the market, including reporting and surveillance.

• Leverage knowledge of the North American regulatory affairs framework.

• Organize, prioritize, and contribute to work and projects in a structured and efficient manner.

• Collaborate successfully within a team environment.

• Execute additional tasks, duties, and responsibilities as assigned.

⛳️ Requirements

• Strong understanding of the North American regulatory affairs framework.

• Knowledge of the requirements and processes for maintaining a product in the market, including reporting and surveillance.

• Familiarity with drug development and associated concepts.

• Capability to assess and grasp regulatory guidelines.

• Excellent written and verbal communication abilities.

• Proficiency in working effectively within a team setting.

• Capacity to organize, prioritize, and contribute to work and projects in a systematic and efficient manner.

• Bachelor's, Master's, or PhD degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science discipline.

• Generally requires 8 years of experience in the pharmaceutical or biotech industry, or in a related field, or an equivalent combination of education and experience.