Regulatory Operations Principal Specialist

About the role

Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable.The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as…

What you'll do

• Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites
• Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations
• Responsible for to coordinate with CRO and ensure that project complete with in timeline
• Designs scientific experiments. Actively and personally monitor lab work. Recommends expansion or curtailment of investigations on the basis of experimental results or…
• Responsible for the preparation of test methods, technical documents, protocols and reports whenever required

What you need

• 7–9 yrs of experience
• Compliance
• HPLC
• Regulatory affairs
• SOP writing
• CRO
• GMP
• PhD or B.Tech or B.E. or Diploma

Good to have

• MIS reporting
• Clinical research