Regulatory Affairs Manager

Job Description:

The Regulatory Affairs Manager is the primary point of contact and responsible for facilitating regulatory oversight and management in all phases of drug development. Managing multidisciplinary teams and client interactions to ensure key regulatory milestones and timelines are met.



Responsibilities:

• Advise clients on current FDA regulations, policies, and guidance's applicable to CDER and CBER.


• Provide regulatory strategy and guidance on FDA requirements for meetings and applications.


• Serve as the US agent or Regulatory Contact on behalf of the Sponsor for FDA interactions.


• Lead the regulatory process for FDA Meetings, ODDs, DMFs, INDs and any regulatory submissions for product life cycle management.


• Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operation...