Manager, Regulatory Affairs

Overview

Regulatory Affairs Manager to oversee regulatory activities for assigned products/projects and represent Regulatory Affairs on cross-functional project teams.

What you'll do

• Represent Regulatory Affairs on assigned product and related project teams.
• Provide regulatory guidance, requirements, and strategy for assigned projects.
• Serve as the primary interface with FDA and other health authorities for assigned products.
• Drive regulatory strategies for drug product registration and life-cycle management across global markets, with primary responsibility for North America submissions.
• Manage regulatory filings including IND, NDA, ANDA, and NDS for multiple dosage forms.
• Manage timelines and operational aspects of preparing compliant regulatory submissions.

What you'll need

• 8-10 years in the pharmaceutical industry with at least 8 years in regulatory affairs.
• Bachelor of Science or preferred advanced healthcare discipline degree (e.g., PharmD, PhD, Master of Science) or equivalent.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing.
• MS Office skills are required.
• Experience working with cross-functional teams, including external partners.
• Ability to work independently with minimal supervision in a fast-paced, deadline-driven environment.

Details

• Location: Hyderabad, IN.