Principal Consultant, CMC

Opus Regulatory, Inc.; Durham (NC); Remoto; USD 210.000 - 300.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) plan

Comprehensive health benefits (medical

Dental, Vision, Prescription coverage

Life Insurance

Short-Term Disability

Employee Assistance Program (EAP)

Generous paid time off: 20 vacation, 5

10 paid company holidays

Descrizione del lavoro

Opus Regulatory, Inc. seeks Principal Consultants to join its CMC Practice, delivering strategic regulatory guidance and hands-on execution for development, registration, and commercialization. As embedded client team members, you will craft submission strategies, lead deliverables, and interface with client stakeholders and regulators.

You will join a team that values solving complex regulatory challenges and driving client success across diverse product types and therapeutic areas.

Competenze

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Broad CMC regulatory experience across product types (small molecules, biologics, etc.).
• Strong knowledge of global CMC regulatory requirements, submission pathways, eCTD, and lifecycle management.

Mansioni

• Serve as a CMC regulatory expert for development and commercial programs, guiding strategy and addressing regulatory risks.
• Develop and implement global CMC submission strategies aligned with client objectives and regulatory requirements.
• Lead preparation, authoring, and review of CMC submission content (CTD Module 2 summaries, Module 3 sections).
• Provide strategic input for regulatory filings (INDs, NDAs, BLAs, MAAs, amendments, supplements).
• Lead CMC preparation for FDA and global regulatory meetings with materials and team coordination.

Conoscenze

CMC regulatory expertise

Strategic guidance

Regulatory submissions

Project management

Communication

Formazione

Bachelor’s degree in a scientific discipline

Advanced scientific degree preferred

Descrizione del lavoro

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 hiringPrincipal 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.

$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.