CMC Regulatory Consultant, remote

CMC Regulatory Consultant

Position Overview:

We are seeking an experienced Chemistry, Manufacturing, and Controls (CMC) Regulatory Consultant to support our CMC practice area and guide clients through the various stages of drug development. This individual will leverage their scientific and regulatory expertise in CMC to ensure clients meet regulatory requirements while navigating complex development processes. The role will involve close collaboration with multidisciplinary teams to deliver tailored solutions that address client-specific needs, as well as contributing to business development and growth of the CMC practice area.

Key Responsibilities:

Regulatory Documentation: Write and review the CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Investigator’s Brochures (IBs), meeting briefing packages, annual reports) and other strategic development documents (e.g., gap analyses, development plans).
Regulatory Advisory: Advise clients on regulatory requirements from agencies like the FDA, Health Canada, and EMA. Provide regulatory guidance on drug substance and drug product quality expectations, tailored to the stage of development and eventual commercial presentation.
CMC Strategy & Risk Assessment: Offer strategic advice regarding CMC development activities, ensuring alignment with regulatory guidelines. Evaluate CMC-related risks and support clients in developing risk mitigation strategies.
Source Documentation & Assessment: Review source documents, manufacturing processes, raw materials, and methods used by contract manufacturing organizations (CMOs) and other partners to ensure compliance with regulatory standards.
Cross-Functional Collaboration: Collaborate with other practice areas, such as nonclinical and clinical, to ensure integrated development strategies across the entire drug lifecycle.
Regulatory Communication: Serve as the subject matter expert for all CMC-related inquiries, responding to regulatory agency questions, participating in teleconferences, and providing written and oral responses to regulators and clients.
Project Management: Track project progress, manage timelines, and ensure deliverables meet client expectations. Communicate effectively with internal teams, project managers, and clients, escalating issues as needed.
Training & Mentorship: Provide training and mentorship to internal staff, clients, and external vendors on CMC regulatory processes, best practices, and compliance standards.
Quality Standards: Adhere to organizational quality standards, supporting or participating in quality assurance activities as required.
Business Development: Identify opportunities for new business and contribute to growing client relationships. Support efforts to expand the organization’s CMC regulatory consulting services, including proposal preparation and scope development.
Continuous Learning: Stay current on CMC regulatory developments, industry trends, and evolving guidelines to ensure all services are of the highest quality and aligned with the latest standards.

Success Factors:

Clear Communication: Ability to communicate effectively in both written and verbal formats, tailoring messages to different audiences and ensuring clarity and conciseness.
Problem Solving: Ability to think creatively and quickly in fast-paced situations, providing thoughtful and effective solutions to emerging regulatory challenges.
Regulatory Insight: Strong understanding of CMC regulatory requirements and ability to interpret and apply them across the product lifecycle, including drug development and post-approval phases.
Client Relationship Management: Proven ability to build and maintain client relationships, anticipate client needs, and develop strategies that address those needs effectively.
Collaboration & Leadership: Work well both independently and as part of a cross-functional team. Demonstrate the ability to lead projects and collaborate across departments to achieve common goals.
Attention to Detail: Demonstrated ability to produce high-quality work with attention to detail, ensuring completeness and accuracy in all deliverables.
Business Development Acumen: Ability to contribute to business development efforts by identifying opportunities, building client relationships, and growing the organization’s resources.
Mentorship: Ability to mentor and coach staff, helping to develop their skills and ensure they meet organizational standards.

Minimum Qualifications:

Experience: A minimum of 8 years of CMC or quality-focused regulatory experience within the pharmaceutical industry, with prior FDA experience and/or regulatory consulting experience strongly preferred.
Education: Ph.D. in Chemistry, Biochemistry, or a closely related discipline, or an M.S. in a relevant scientific field with extensive experience in CMC regulatory affairs.
Expertise: Deep understanding of CMC requirements and strategy throughout the product lifecycle, including drug development and post-approval. Familiarity with ICH, FDA, EMA, and other regulatory bodies' guidelines and standards is essential.
Regulatory Document Preparation: Experience with the preparation of regulatory submissions in CTD format, including IBs, Briefing Packages, INDs, CTAs, NDAs, and MAAs.
CMC Strategy & Risk Management: Experience in CMC strategy development, data interpretation, and risk assessment.
CMC & CMO Interaction: Knowledge of contract manufacturing processes and the ability to guide interactions with CMOs/laboratories to ensure compliance with regulatory requirements.
Regulatory Agency Interaction: Experience interacting with regulatory agencies, especially the FDA, on INDs, NDAs, and development programs. Experience with other agencies (EMA, Health Canada) is a plus.
Device and Biologics Experience: Experience with device regulations, combination products, or biologics is a plus.
Business Development: Experience supporting business development activities, including proposal writing and client relationship management, is a plus.
Technical Skills: Proficiency in Microsoft Office Suite and other relevant software tools.
Eligibility: Must be eligible to work in the U.S. without restrictions.

This is an exciting opportunity for a seasoned regulatory professional with a passion for CMC and drug development. If you’re ready to make an impact in a growing organization and drive innovative regulatory strategies for clients, we encourage you to apply.