Senior Manager, Regulatory Affairs

The role

The Senior Manager, Regulatory Affairs will oversee and manage regulatory activities for assigned products and projects. This person will serve as the regulatory representative on cross-functional teams for developmental and life-cycle management projects.

What you will do

• Represent Regulatory Affairs on assigned product and related project teams
• Provide regulatory assessment of due diligence requests for new business development
• Serve as primary interface with FDA and Health Canada for assigned products
• Prepare and author portions of Health Authority meeting request and briefing documents
• Attend Health Authority meetings as assigned
• Drive regulatory strategies for drug product registration and life-cycle management across North America
• Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for various dosage forms
• Respond to FDA or Health Canada Requests for Information
• Manage operational aspects of preparing compliant submissions
• Establish and manage timelines associated with regulatory submissions

Required qualifications

• Minimum Bachelor of Science
• Minimum of 10 years in the pharmaceutical industry
• At least 8 years in regulatory affairs
• Excellent organizational, interpersonal, verbal, and written communication skills
• Strong grammar and proofreading/editing skills
• MS Office skills
• Track record of successfully working with cross-functional teams, including external partners
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment
• Keen attention to detail
• Ability to rapidly adapt to changing environment and circumstances
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders

Nice to have

• Advanced health care discipline degree (PharmD, PhD, Master of Science, etc.)

About the company

Azurity Pharmaceuticals is a company with more than 70 medicines across 11 therapeutic areas reaching millions of people in more than 50 countries. They focus on repurposing proven molecules and reimagining how therapies are designed, delivered, and accessed.