Associate Director, Regulatory Submissions Strategy - Remote

Overview

The Associate Director, Regulatory Submissions Strategy is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. The position is responsible for oversight and execution of global regulatory activities, for product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.) and regulatory compliance.

In Short

• Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members.
• Communicate creative ideas and manage regulatory aspects of projects in collaboration with multidisciplinary teams.
• Develop and communicate regulatory strategies and plans that align with project objectives.
• Direct and lead execution plans for regulatory submissions.
• Proactively identify potential program and/or submission risks and implement appropriate regulatory mitigation strategies.
• Lead the coordination and authoring of regulatory meeting packages.
• Manage and oversee regulatory activities relating to clinical trials.
• Determine and communicate documentation requirements for submissions.
• Prepare/author documents in collaboration with CRO/regulatory vendors.
• Review submission components to ensure compliance with health authority expectations.

Requirements

• Bachelor’s degree in Life/Health Sciences required; Master’s degree and/or Ph.D. a plus.
• Minimum of 7 years of experience in pharmaceutical/biotech with a minimum of 4+ years in clinical Regulatory Affairs.
• Comprehensive knowledge of current US regulations and guidelines.
• Experience in contributing to briefing books and submission packages for Regulatory Authority meetings.
• Strong project management skills.
• Ability to grasp complex technical issues and make sound decisions based on data.

Benefits

• The base salary range for this role is $175,750 - $194,250.
• Avidity offers competitive compensation and benefits including bonuses, stock options, and a 401(k) with employer match.
• Comprehensive wellness program including medical, dental, vision, and four weeks of time off.
• Commitment to learning and development with various training opportunities.