Assistant Manager – Submission Publishing

About the role

Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

What you'll do

• Interacts with regulatory agency to expedite approval of pending registration
• Serves as regulatory liaison throughout product lifecycle
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC)
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products
• Serves as regulatory representative to marketing, research teams and regulatory agencies

What you need

• Research
• Regulatory affairs
• Chemistry
• Any graduate