Manager, Regulatory Affairs, Tactical Implementation (Pharmaceuticals)

TL;DR

Manager, Regulatory Affairs, Tactical Implementation (Pharmaceuticals): Execution and oversight of global regulatory submission activities for patients with serious diseases with an accent on documentation workflow and compliance. Focus on authoring regulatory documents, managing submission lifecycles, and coordinating across cross-functional teams.

Location: Remote (Must be based in the US)

Salary: $133,000 – $173,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage project timelines and documentation workflows for global regulatory submissions including INDs, CTAs, NDAs, BLAs, and MAAs.
• Author and oversee the preparation of regulatory documents, briefing books, and meeting materials.
• Lead the end-to-end document lifecycle, encompassing creation, review, approval, and archival.
• Coordinate with cross-functional teams such as Clinical, Nonclinical, and CMC to ensure alignment on deliverables.
• Monitor new regulations and guidelines to ensure internal processes and deliverables remain compliant.
• Maintain and archive regulatory files using the Veeva Vault Document Management System.

Requirements

• Bachelor’s degree.
• 5+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Strong knowledge and understanding of regulatory guidances and documentation standards.
• Proficiency in MS Office applications and Adobe Acrobat.
• Eligibility for US-based employment benefits.

Nice to have

• Experience with SmartSheet or other project management software.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with competitive company match and annual equity awards.
• Generous paid time off policies and flexible work schedules.
• Access to Company Learning Institute, LinkedIn Learning, and leadership programs.
• Employee resource groups and meaningful opportunities to volunteer.