Senior Director, Regulatory Affairs CMC – Small Molecule

We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use

for each heading. Use

• for any list of duties/requirements/benefits. Use

  for prose. Do not repeat job title as heading. Do not put Job ID/requisition numbers as headings. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Preserve all substantive info. Include a section only when posting has real, specific content for it. Avoid filler like "commensurate with experience", "not specified", etc. So we need to extract sections. From posting: - About Beeline Medicines (company description) maybe "About the role"? Actually "About Beeline Medicines" is company overview. Could be placed under "About the role"? The instruction: use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content accordingly. We have: - Job Summary (description of role) -> could be "About the role". Provide prose. - Work Arrangement & Location: Hybrid schedule details -> could be "Schedule". Provide details. - Essential Duties And Responsibilities -> list of duties -> "Responsibilities". - Qualifications -> includes Education, experience, expertise etc. Could be "Qualifications". Also there is "Skills" maybe separate? The qualifications list includes many skill-like items. Could split: Qualifications (education, experience) and Skills (specific abilities). But we need to avoid thin sections. Might combine Qualifications and Skills into one? But instruction says prefer a few substantive sections over many thin ones. We could have sections: About the role, Responsibilities, Qualifications, Benefits, Pay, Schedule. Possibly also Skills if distinct. Let's extract: About the role: Job Summary paragraph plus maybe company description? The "About Beeline Medicines" is company overview, not role. Could be included in About the role as context. But we can keep it as part of About the role. Responsibilities: list of duties (the bullet points under Essential Duties And Responsibilities). Each bullet is a sentence; we can make

  • . Qualifications: Education, experience, expertise etc. Could be a mix of prose and list. We'll make
    • for each qualification item. Skills: maybe the abilities like "Strong command of post-approval CMC change management regulations", "Proven track record of influencing without authority", etc. Those are also qualifications. Might be redundant. Could combine Qualifications and Skills into one section called Qualifications (includes skills). But we need to follow headings list; we can omit Skills if not distinct. Benefits: described under "Benefits". Provide list. Pay: Salary Range $242,000 - $313,500 USD plus note about bonus etc. Provide prose. Schedule: Work Arrangement & Location: Hybrid schedule details. We must not include boilerplate: Equal Employment Opportunity, Reasonable Accommodation, Privacy, etc. Also remove duplicated lines. Now produce HTML. Structure:

      About the role

      ... (company overview + job summary)

      Responsibilities

      • ...
      ...

      Qualifications

      • ...
      ...

      Benefits

      • ...
      ...

      Pay

      ...

      Schedule

      ...

      Make sure no extra sections. Now extract content. About the role: Combine company overview and job summary. Company overview: "Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully." Job Summary: "The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's small molecule assets within the immunology and inflammation (I&I) portfolio. This role is responsible for developing and executing CMC regulatory strategies from early clinical development through NDA filing and post-approval lifecycle management, serving as the company's foremost authority on small molecule CMC regulatory science. The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure that CMC programs are designed, documented, and submitted in full alignment with FDA, EMA, and global Health Authority expectations. As a senior leader within the Regulatory Affairs organization, this individual also contributes to the broader regulatory strategy, and plays a key role in shaping the company's regulatory affairs infrastructure" Combine into one paragraph maybe two sentences but okay. Now Responsibilities list: extract each bullet. From text: - Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio, from IND/CTA through NDA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product. - Author, review, and oversee the preparation of CMC sections of global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, MAAs, Type II variations, and supplements, with accountability for quality, completeness, and regulatory defensibility. - Serve as the company's primary regulatory authority and strategic partner for small molecule Technical Development, Process Chemistry, Analytical Development, Formulation Sciences, and Quality functions on all CMC regulatory matters. - Lead Health Authority interactions related to small molecule CMC topics, including FDA Type B and Type C meetings, EMA Scientific Advice meetings, and written responses to CMC deficiency letters and information requests from global regulatory agencies. - Provide expert regulatory interpretation of FDA, EMA, and ICH CMC guidance documents applicable to small molecules, including ICH Q8, Q9, Q10, Q11, and Q12, and proactively advise development teams on design space, process validation, and control strategy regulatory acceptability. - Lead post-approval CMC change management strategy for small molecule programs, including SUPAC assessments, Prior Approval Supplements (PAS), Changes Being Effected (CBE) filings, and ex-US variation submissions. - Oversee regulatory aspects of small molecule technology transfer activities, including new CMO onboarding, site-to-site comparability, and associated regulatory filing updates. - Establish and maintain CMC regulatory SOPs, templates, and document management workflows specific to small molecule programs, ensuring compliance with ICH CTD, eCTD, and applicable electronic submission requirements. - Contribute to regulatory due diligence evaluations of small molecule licensing candidates or acquisition targets, providing CMC regulatory risk assessment and readiness analysis. - Tracks CMC regulatory deliverables and submission timelines across all small molecule programs, ensuring proactive identification of dependencies, risks, and upcoming milestones to keep cross-functional teams aligned and submission-ready. - Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence. - Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership. - Perform other duties and responsibilities as assigned We'll keep as list. Qualifications: list items. From Qualifications section: - Education: Advanced degree (PhD, MS, or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry, or a related small molecule-relevant discipline strongly preferred. - Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry preferred - Deep and comprehensive expertise in small molecule CMC regulatory strategy, including drug substance (API) synthesis and control, drug product formulation and manufacturing, and analytical method development and validation for oral, parenteral, and other dosage forms. - Extensive experience authoring and overseeing small molecule CMC sections of global regulatory submissions, including INDs/CTAs, NDAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format. - Demonstrated track record of leading FDA and EMA CMC-focused Health Authority meetings, including preparation of briefing documents and strategic management of written responses to CMC deficiency letters - Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12 guidelines, FDA small molecule CMC guidance documents (e.g., SUPAC, process validation, container closure), and EMA quality guidance applicable to small molecule chemical entities. - Proven experience managing CMC regulatory aspects of technology transfer, new CMO qualification, and site change regulatory filing strategies for small molecule programs. - Strong command of post-approval CMC change management regulations, including SUPAC categories, PAS/CBE filing requirements, and ex-US variation frameworks. - Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning. - Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities. - Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy. - Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners. - Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies. - Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations; balances clarity, diplomacy, and scientific precision We'll make each as
    • . Benefits: list. From Benefits section: - Competitive health and wellness coverage (structure and premiums vary by country) - Paid time off, public holidays, and additional leave entitlements in accordance with local requirements - Flexible work arrangements / hybrid schedule - Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process. We'll make list items. Pay: Salary Range $242,000 - $313,500 USD plus note about bonus etc. From Salary Range section: "The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance. Salary Range $242,000 - $313,500 USD" We'll combine into paragraph. Schedule: Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction. We'll put as paragraph. Now ensure no boilerplate: removed EEO, Reasonable Accommodation, Privacy. Now output HTML fragment