Director, Regulatory CMC
Nuvation Bio · United States · 1 mo ago
RemoteRemoteLegalFull-time
We need to output HTML fragment with sections: About the role? The posting includes "Who We Are…" then "What You’ll Be Doing" then "What Knowledge & Experience You'll Bring To Us..." then "Behavioral Skills To Be Successful..." then "What we have for you!" (benefits). Also there is a disclaimer etc which we need to remove.
We must not repeat job title as heading. Use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to map content to these headings appropriately.
We have "Who We Are" - could be About the role? Actually "Who We Are" is company description, could be About the role? Usually "About the role" is description of role. But we have "What You’ll Be Doing" which is responsibilities. So we can put "About the role" heading with company description? Might be better to put "About the role" as a brief overview of the role (maybe combine Who We Are and What You’ll Be Doing?). However instructions: Use headings only when posting has real, specific content for it. We have content for Responsibilities (What You’ll Be Doing). We have content for Requirements/Qualifications/Skills (What Knowledge & Experience You'll Bring To Us... plus Behavioral Skills). We have Benefits (What we have for you!). Pay: posting mentions "Competitive Base Salary, Bonus, and Equity Plans" and later "The base pay offered will take into account internal equity..." So we have pay info. Schedule: not mentioned (no schedule). So we should not include Schedule section.
We need to avoid filler like "commensurate with experience". Not present.
We need to use
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to map content to these headings appropriately.
We have "Who We Are" - could be About the role? Actually "Who We Are" is company description, could be About the role? Usually "About the role" is description of role. But we have "What You’ll Be Doing" which is responsibilities. So we can put "About the role" heading with company description? Might be better to put "About the role" as a brief overview of the role (maybe combine Who We Are and What You’ll Be Doing?). However instructions: Use headings only when posting has real, specific content for it. We have content for Responsibilities (What You’ll Be Doing). We have content for Requirements/Qualifications/Skills (What Knowledge & Experience You'll Bring To Us... plus Behavioral Skills). We have Benefits (What we have for you!). Pay: posting mentions "Competitive Base Salary, Bonus, and Equity Plans" and later "The base pay offered will take into account internal equity..." So we have pay info. Schedule: not mentioned (no schedule). So we should not include Schedule section.
We need to avoid filler like "commensurate with experience". Not present.
We need to use - for any list of duties/requirements/benefits. So we need to convert responsibilities into list items. Also requirements/qualifications/skills into list items. Benefits into list.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep the details but can format as list items.
We must not include boilerplate like EEO, disclaimer, note to recruiters, etc.
We need to output only HTML fragment, no /, no markdown fences.
Let's extract sections:
About the role: Could be a brief paragraph summarizing role: maybe combine "Who We Are" and "What You’ll Be Doing"? But "Who We Are" is company description, not role. However we could still put under About the role a short paragraph describing the role: "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..." That's from What You’ll Be Doing first sentence. So we can put that as About the role paragraph.
Responsibilities: list of duties from "You will be responsible for…" bullet list (the long list). We'll extract each sentence starting with a verb.
Requirements: maybe "What Knowledge & Experience You'll Bring To Us..." includes advanced degree, years experience, etc. We'll list.
Qualifications: maybe overlapping with Requirements; but we can split: Requirements = experience/education; Qualifications = specific skills like expert understanding, proven ability, etc. Skills = behavioral skills.
But we need to avoid thin sections. Could combine Requirements and Qualifications into one? But we have headings list; we can use multiple if substantive.
We have "What Knowledge & Experience You'll Bring To Us..." which includes education, experience, small molecule expertise, expert understanding, proven ability, communication skills, oversight, proficiency, organized. That's a mix of qualifications and skills.
Then "Behavioral Skills To Be Successful..." lists problem-solver, personable, credible, emotional intelligence, communication, accountability, adaptability.
Thus we can have:
- Requirements: Education + years experience + small molecule experience.
- Qualifications: Expert understanding of global Regulatory CMC requirements, proven ability to interpret complex technical CMC information, excellent written and verbal communication skills, demonstrated ability to provide oversight of external consultants, advanced proficiency in authoring/reviewing Module 3/CMC sections, highly organized, self-motivated, capable of leading multiple products.
- Skills: Behavioral skills list.
Benefits: "What we have for you!" includes 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. Also mention base pay varies etc. We'll include those as list.
Pay: we have info about base pay taking into account internal equity, may vary depending on candidate’s job-related knowledge, skills, experience, location; full-time regular positions also include annual performance-based bonus and long-term incentive units (equity). This overlaps with Benefits but we can still have Pay section detailing base salary, bonus, equity. However we already listed Competitive Base Salary, Bonus, and Equity Plans under Benefits. To avoid duplication, maybe we put Pay section with details about base salary variability and bonus/equity, and Benefits section with vacation, medical, 401K. But we must not create thin sections; both have substantive content.
Let's decide:
Pay section: "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."
Benefits section: "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!" But that duplicates base salary etc. Might be okay but could be considered duplication. However instructions: Preserve ALL substantive information; do NOT invent or summarize away detail. If we duplicate, we are preserving both statements. It's okay.
But we should avoid repeating same info verbatim? Not prohibited. We'll keep both.
Now we need to format lists.
Let's craft HTML:
About the role
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.
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.
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.
- 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.
Qualifications
- 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.
Skills
- Problem‑Solver – action‑oriented self‑starter eager to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable – establishes and nurtures 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, quickly establishes 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; strong presenter and effective communicator with
About the role
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.
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.
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.
- 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.
Qualifications
- 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.
Skills
- Problem‑Solver – action‑oriented self‑starter eager to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable – establishes and nurtures 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, quickly establishes 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; strong presenter and effective communicator with