Director, Regulatory CMC

Nuvation Bio•Remote - Any State US, NY

About The Position

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. The Director of Regulatory CMC is responsible for leading the strategic development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across the company portfolio from early-stage discovery through all clinical phases to product registration and post-approval commercialization, as applicable. The primary focus is on managing clinical trial applications, marketing authorizations, and ensuring absolute compliance with global health authority regulations for both drug substance and drug product. This role also serves as the critical regulatory liaison to bridge technical operations, quality assurance, and clinical development findings into compliant, high-quality, and inspection-ready global regulatory submissions.

Requirements

Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related discipline
Generally 10+ years of pharmaceutical industry experience, including substantial experience in Regulatory CMC and increasing responsibility for global regulatory strategy.
Demonstrated ability to lead preparation, review, and delivery of CMC content for global regulatory submissions across clinical development, marketing application, post-approval, and lifecycle management stages.
Strong experience with small molecule drug development and commercialization, including clinical trial applications, marketing applications, post-approval changes, manufacturing site transfers, supplier changes, stability strategies, and product lifecycle management activities.
Expert understanding of global Regulatory CMC requirements, including ICH guidelines, cGMP expectations, compendial standards, and FDA, EMA, NMPA, MFDS, and other health authority requirements and expectations.
Proven ability to interpret complex technical CMC information, assess regulatory impact, and translate data into clear, scientifically sound, and regulatory-appropriate submission content, briefing materials, justifications, and health authority responses.
Excellent written and verbal communication skills, with a demonstrated ability to influence, advise, and collaborate effectively with cross-functional teams, senior leadership, external partners, and regulatory authorities.
Demonstrated ability to provide oversight of external consultants, CMOs, CDMOs, and contract laboratories to ensure timely delivery of high-quality CMC information in support of regulatory submissions, health authority commitments, and business objectives.
Advanced proficiency in authoring and reviewing Module 3/CMC sections, briefing documents, responses to information requests, annual reports, supplements, variations, and other regulatory submission documents.
Highly organized, self-motivated, and capable of leading multiple products, projects, timelines, regulatory deliverables, and cross-functional priorities in a fast-paced environment.
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence , curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Responsibilities

Lead the development, execution, and lifecycle management of global Regulatory CMC strategies for clinical-stage and commercial products.
Lead, author, review, and critically assess CMC regulatory documents and technical reports to ensure accuracy, consistency, scientific rigor, and suitability for global regulatory filings.
Provide strategic Regulatory CMC leadership and guidance to process chemistry, formulation development, analytical, quality, manufacturing, clinical, supply chain, and commercial teams to ensure development and lifecycle activities are aligned with global regulatory expectations.
Oversee planning, preparation, and delivery of high-quality CMC sections for INDs, CTAs, IMPDs, NDAs/MAAs, amendments, supplements, variations, annual reports, and responses to health authority questions.
Evaluate complex CMC changes, including manufacturing process, analytical method, specification, stability, packaging, supplier, and manufacturing site changes, and define appropriate global regulatory reporting and submission strategies.
Lead Regulatory CMC gap assessments of source documents, development reports, manufacturing records, validation packages, specifications, stability data, and quality documents to identify filing risks, compliance gaps, and remediation plans.
Direct and coordinate interactions with CMOs, CDMOs, contract laboratories, consultants, and internal functions to obtain, review, and finalize CMC documentation required for regulatory submissions, commitments, and lifecycle management activities.
Provide in-depth Regulatory CMC review of manufacturing, analytical, stability, validation, and quality information to support development programs and global regulatory submissions.
Lead CMC-related interactions with regulatory authorities, including preparation of briefing materials, meeting packages, information request responses, written commitments, and strategic negotiation positions.
Ensure CMC submission content is complete, consistent, scientifically justified, and compliant with applicable ICH, FDA, EMA, NMPA, MFDS, and other global health authority expectations.
Drive cross-functional alignment with Regulatory Affairs, Quality, Technical Operations, Supply Chain, Clinical, Commercial, and Program Management teams to identify CMC regulatory risks, develop mitigation plans, and achieve submission deliverables and timelines.
Manage and provide oversight of Regulatory CMC contributions from external consultants and subject matter experts to support regulatory strategy, submission planning, authoring, health authority responses, inspections, audits, due diligence, and product lifecycle activities.
Monitor global Regulatory CMC trends, guidance updates, and precedents to inform regulatory strategy, risk assessments, and continuous improvement of submission quality and compliance.
Represent Regulatory CMC in inspections, audits, due diligence activities, governance discussions, and cross-functional decision-making forums, as required.