Regulatory Affairs Senior Consultant (CMC)

Overview

We are looking for a motivated Senior Consultant to join our team. You will provide high-quality regulatory advice on human medicinal products and support product development.

Key Responsibilities

• Provide strategic and regulatory advice on CMC aspects of drug development
• Develop drug development plans, gap analyses, and international regulatory strategies
• Author and review regulatory documents, including CTAs, INDs, MAAs, BLAs, IMPDs, and pediatric plans
• Lead multi-country projects and represent clients in regulatory interactions
• Manage project timelines, budgets, and internal/external meetings
• Support business development and mentor team members

Requirements

• BSc in life/physical sciences; MSc or PhD preferred
• Minimum 5 years of drug development experience
• Minimum 5 years of regulatory experience (FDA, EMA, MHRA or national authority)
• Experience authoring CMC sections of regulatory submissions; MAA/BLA experience preferred
• Experience across a range of products, including biologics, vaccines, ATMPs, RNA/DNA therapeutics, and small molecules
• Proven ability to provide strategic regulatory planning from early development to marketing authorization
• Strong leadership, mentoring, and communication skills
• Highly organized, detail-oriented, and able to work independently
• Willingness to work flexible hours and travel as needed

Why Join Us

• Influence global product development
• Interact directly with regulatory authorities
• Lead and mentor a growing team
• Work remotely while collaborating internationally