Job Description

What you'll be doing

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.
You will be responsible for...

• Lead thedevelopment, execution, and lifecycle management of global Regulatory CMCstrategies for clinical-stage and commercial products.
• Lead, author,review, and critically assess CMC regulatory documents and technical reports toensure accuracy, consistency, scientific rigor, and suitability for globalregulatory filings.
• Providestrategic Regulatory CMC leadership and guidance to process chemistry,formulation development, analytical, quality, manufacturing, clinical, supplychain, and commercial teams to ensure development and lifecycle activities arealigned with global regulatory expectations.
• Overseeplanning, 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.
• Evaluatecomplex CMC changes, including manufacturing process, analytical method,specification, stability, packaging, supplier, and manufacturing site changes,and define appropriate global regulatory reporting and submission strategies.
• LeadRegulatory CMC gap assessments of source documents, development reports,manufacturing records, validation packages, specifications, stability data, andquality documents to identify filing risks, compliance gaps, and remediationplans.
• Direct andcoordinate interactions with CMOs, CDMOs, contract laboratories, consultants,and internal functions to obtain, review, and finalize CMC documentationrequired for regulatory submissions, commitments, and lifecycle managementactivities.
• Providein-depth Regulatory CMC review of manufacturing, analytical, stability,validation, and quality information to support development programs and globalregulatory submissions.
• LeadCMC-related interactions with regulatory authorities, including preparation ofbriefing materials, meeting packages, information request responses, writtencommitments, and strategic negotiation positions.
• Ensure CMCsubmission content is complete, consistent, scientifically justified, andcompliant with applicable ICH, FDA, EMA, NMPA, MFDS, and other global healthauthority expectations.
• Drivecross-functional alignment with Regulatory Affairs, Quality, TechnicalOperations, Supply Chain, Clinical, Commercial, and Program Management teams toidentify CMC regulatory risks, develop mitigation plans, and achieve submissiondeliverables and timelines.
• Manage andprovide oversight of Regulatory CMC contributions from external consultants andsubject matter experts to support regulatory strategy, submission planning,authoring, health authority responses, inspections, audits, due diligence, andproduct lifecycle activities.
• Monitorglobal Regulatory CMC trends, guidance updates, and precedents to informregulatory strategy, risk assessments, and continuous improvement of submissionquality and compliance.
• RepresentRegulatory CMC in inspections, audits, due diligence activities, governancediscussions, and cross-functional decision-making forums, as required.

What Knowledge & Experience you'll bring to us...

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related discipline with 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.

Behavioral skills to be successful...

• 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.

What we have for you!

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!

The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.