Senior Associate, Regulatory Affairs CMC

• Job Profile Summary
  
  

Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. Prepares and directs the development of CMC submissions including initial market registrations, progress reports, supplements, amendments, and/or periodic experience reports. Represents company during communications and meetings with health authorities. Interacts and negotiates with regulatory agencies in order to expedite approval of pending registration and answer any questions. Participates in identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance.

• Job Description
  
  

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 ...