Principal Consultant, CMC

About Opus Regulatory:

Founded in 1994, Opus Regulatory (Opus) is a consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Advertising & Promotion. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Backed by Audax Private Equity, Opus has grown to roughly 120 consulting professionals across the US and UK. Our team is made up of biopharmaceutical leaders and innovators, and our mission is to provide the highest level of Regulatory Affairs consultancy in the industry—continually exceeding client expectations through excellence, partnership, and integrity.

Location: Remote | Levels: Associate Director to VP

Role Overview

We are hiring for Principal Consultant, Regulatory Affairs CMC roles, who will primarily be responsible for the daily management of regulatory requirements for one or more drug products, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities. We have a robust client portfolio offering a variety of projects including therapeutic areas.

Key Responsibilities

• Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks

• Provide high-level strategy input on critical regulatory filing documents (e.g., meeting packages/briefing books (FDA Interact, pre-INDs, Type A, B, C, D), scientific advice, INDs, IMPDs, BLAs, MAAs, NDAs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics. Perform final review and approval for all global submissions for the portfolio to ensure alignment with program regulatory strategy and development plan.

• Provide oversight for interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).

• Lead and facilities activities, including team preparation, for meetings with FDA and other regulatory authorities for CMC development activities

• Experience in authoring complex technical documents, CMC regulatory CTD (M2 and M3) sections, and life cycle management.

• Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks

• Perform RA-CMC compliance activities to support IOPS organization.

• Monitor emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate).

Qualifications

• Minimum experience: A minimum of 10 years’ pharmaceutical/biotech industry experience.
• Minimum of 5 years of relevant, but broad, regulatory affairs CMC experience in the areas of gene therapies, small and large molecules (biologics), vaccines, and combination of products/devices.

• Background in scientific discipline and expertise in at least one area in pharmaceutical development (e.g., chemical process, formulation, manufacturing, QC, QA, etc.).

• Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred).

• Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.

• Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.

• Regulatory submission knowledge, including eCTD and NDA/IND requirements.

• Steadfast attention to detail; ability to identify and communicate methods for improving existing processes.

• Ability to work in an ever-changing pharmaceutical environment.

• Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.

• Ability to work collaboratively and direct the work of others toward common goals.

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.