Principal Consultant, CMC

About Opus Regulatory:

Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.

Multiple Openings | Remote | Associate Director–VP Experience Levels

Opus Regulatory’s CMC Practice is hiring Principal Consultants to support pharmaceutical and biotechnology clients across a variety of products, development stages, and therapeutic areas.

In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients navigate CMC requirements throughout product development, registration, and commercialization. As an embedded member of client teams, you will develop submission strategies, lead regulatory deliverables, and build strong relationships with client stakeholders and regulatory authorities.

We welcome candidates with experience at the Associate Director through Vice President levels who enjoy solving complex regulatory challenges and contributing directly to client success.

Key Responsibilities

• Serve as a CMC regulatory expert for development and commercial programs, providing strategic guidance, assessing regulatory risks, and recommending practical solutions.

• Develop and implement global CMC submission strategies aligned with client objectives, development plans, and regulatory requirements.

• Lead the preparation, authoring, and review of CMC submission content, including CTD Module 2 quality summaries and Module 3 sections, to ensure technical accuracy, consistency, and alignment with program strategy.

• Provide strategic input and oversight for regulatory filings, including INDs, IMPDs, NDAs, BLAs, MAAs, amendments, supplements, and required lifecycle updates.

• Lead CMC preparation for meetings with FDA and other global regulatory authorities, including briefing materials, team preparation, and responses to agency questions.

• Support regulatory authority interactions, information requests, and inspection activities in partnership with client teams.

• Guide CMC lifecycle management and regulatory compliance activities, partnering with manufacturing, quality, technical operations, and other stakeholders.

• Monitor emerging CMC regulations and guidance, assess their impact on client programs, and recommend updates to strategies and processes.

Qualifications

• 10+ years of pharmaceutical or biotechnology industry experience, including a minimum of five years of relevant regulatory affairs CMC experience.

• Bachelor’s degree in a scientific discipline required; an advanced scientific degree preferred.

• Broad CMC regulatory experience supporting one or more product types, such as small molecules, biologics, gene therapies, vaccines, or drug-device combination products.

• Scientific and technical expertise in at least one pharmaceutical development area, such as process development, formulation, manufacturing, quality control, or quality assurance.

• Strong knowledge of global CMC regulatory requirements, submission pathways, eCTD structure, and lifecycle management.

• Demonstrated ability to provide both strategic counsel and hands-on support for complex CMC submissions and regulatory authority interactions.

• Strong project management skills, with the ability to coordinate deliverables, manage competing priorities, and guide cross-functional teams toward shared goals.

• Strong communication skills, sound judgment, and attention to detail, with the ability to translate complex technical and regulatory issues into actionable recommendations.

• Ability to work independently and collaboratively, adapt to changing program needs, and identify opportunities to improve regulatory processes.

At Opus Regulatory, we are committed to pay transparency and equitable
compensation practices. Actual compensation will be determined based on factors such
as experience, education, specialized expertise, geographic location, and internal
equity. In select circumstances, compensation may fall outside of the posted range.

US-Remote Pay Range

$210,000—$300,000 USD

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.