Senior US Regulatory Affairs Consultant – FDA Strategy (Hybrid)

DLRC Regulatory Consultancy; Boston (MA); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Flexible working

Professional development

Collaborative culture

Job summary

DLRC Regulatory Consultancy seeks an experienced Regulatory Affairs Consultant to independently lead regulatory projects across the US, EU and UK regulatory landscapes. You will develop and execute regulatory strategies, manage timelines and build strong client relationships with minimal supervision.

Ideal candidates have strong US regulatory development experience, including pre-IND strategy and FDA meeting interactions, and can mentor junior colleagues while contributing to business

Qualifications

• Regulatory affairs professional with US focus.
• Lead regulatory projects end-to-end.
• Prepare NDA/IND submissions.
• Engage with FDA and stakeholders.
• Mentor junior colleagues.

Responsibilities

• Independently advise clients on regulatory development strategies and applicable regulations.
• Lead the development and delivery of regulatory strategies for allocated projects.
• Lead and support pre-IND activities and FDA meeting interactions.
• Prepare, review and oversee INDs and amendments; NDA/BLAs experience advantageous.
• Manage project timelines, budgets and risks; build client relationships.

Skills

Regulatory affairs

FDA regulations

pre-IND strategy

IND submissions

Project management

Client relationships

US Agent responsibilities

Education

Life Sciences degree

Pharmacy degree

Tools

Microsoft Office

Job description

DLRC Regulatory Consultancy seeks an experienced Regulatory Affairs Consultant to independently lead regulatory projects across the US, EU and UK regulatory landscapes. You will develop and execute regulatory strategies, manage timelines and build strong client relationships with minimal supervision.

Ideal candidates have strong US regulatory development experience, including pre-IND strategy and FDA meeting interactions, and can mentor junior colleagues while contributing to business