Principal Consultant, CMC

Job overview

The Principal Consultant, CMC role is fully remote in the United States, with a stated pay range of $210,000–$300,000 per year. Opus Regulatory provides regulatory strategy, CMC, labeling, and advertising and promotion consulting to biopharmaceutical clients. The consultant provides strategic regulatory guidance and hands-on support across product development, registration, and commercialization. The role develops submission strategies, leads CMC deliverables, supports regulatory authority interactions, and helps clients manage compliance and product lifecycle needs.

What you'll do

• Advise on CMC regulatory strategy, risks, and solutions
• develop global submission strategies
• lead authoring and review of CTD Module 2 and Module 3 content
• oversee filings including INDs, IMPDs, NDAs, BLAs, MAAs, amendments, and supplements
• prepare for FDA and other authority meetings
• support information requests and inspections
• guide lifecycle management and compliance
• monitor regulatory guidance.

What we're looking for

Skills & competencies

principal consultant

cmc

remote us

opus regulatory

$210,000–$300,000/year

regulatory affairs

biopharmaceuticals

ctd module 2

ctd module 3

fda interactions

global submissions

lifecycle management

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, prescription coverage, life insurance, short-term disability, employee assistance program, 401(k), 20 vacation days, 5 sick days, and 10 paid company holidays.

Why this role

Remote role with openings for Associate Director through Vice President experience levels; requires 10+ years of pharmaceutical or biotechnology experience.

About the employer

Opus Regulatory is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.