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