Our client is a full-service regulatory affairs and product development consulting firm with over 30 years of experience in the life sciences industry. Founded by former FDA officials, they have built a reputation as a trusted strategic partner for pharmaceutical, biotechnology, and medical device companies seeking to bring innovative products to the US market. Their team of regulatory scientists and industry experts has successfully supported more than 4,700 projects across 58 countries, covering the full product development lifecycle — from early-stage strategy through commercialization. As an employee-owned company (ESOP), they operate with a strong culture of accountability, quality, and long-term commitment to both their clients and their people.
About the Role
As a Regulatory Affairs Manager, you will be the primary point of contact for clients navigating the FDA regulatory process. You will lead regulatory strategy and submissions, manage cross-functional expert teams,
and ensure key milestones and timelines are met across multiple drug development projects simultaneously. This is a fully remote, individual contributor role working with US-based clients and teams in Eastern Time.
What You'll Do
- Advise clients on FDA regulations, policies, and guidance applicable to CDER and CBER
- Serve as US Agent or Regulatory Contact on behalf of sponsor clients in FDA interactions
- Lead the regulatory process for FDA Meetings, INDs, DMFs, ODDs, and product lifecycle submissions
- Provide regulatory strategy and guidance on FDA requirements for meetings and applications
- Lead and coordinate Subject Matter Expert (SME) teams to ensure deliverables are met on time and within budget
- Identify critical regulatory issues and develop strategies to address them in collaboration with SMEs
- Prepare, format, and quality-review regulatory documents in compliance with FDA guideline
📌 Regulatory Affairs Manager (Ciudad de México)
🏢 Rad Hires
📍 Ciudad de México
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