REGULATORY

WHAT WE DO

• Interpret, evaluate and apply US Food and Drug Administration (FDA) and other global health authorities’ regulations and guidance during product development and life cycle management activities 
• Serve as liaisons with global health authorities and internal cross-functional project teams to ensure a timely and efficient product review process 
• Keep abreast of the changing regulatory and legislative environment, leveraging regulatory intelligence to inform decision-making throughout a product’s life cycle for the benefit of patients 
• Review advertising, promotional, and other materials/communications to ensure appropriate messaging to health care providers and consumers/caregivers 
  
  

YOUR KEYS TO SUCCESS

• A strong background in executing innovative drug development strategies and product life cycle management activities 
• Ability to drive innovation with cutting-edge expertise for breakthrough patient solutions 
• Effective communication and strong interpersonal skills, with a demonstrated ability to interface with internal and external stakeholders 
• Confidence to tackle challenging problems and a “can do attitude” to make things happen 
• Thrives in a team environment and has the flexibility to be either a team leader or a team player 
• Be immersed in the external Regulatory landscape to foster creativity and cultivate novel thinking