Senior Director, Regulatory Affairs CMC – Biologics

Job Summary:

The Senior Director, Regulatory Affairs CMC – Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's biologics assets within the immunology and inflammation (I&I) portfolio, including monoclonal antibodies and other large molecule therapeutic modalities. This role is responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and post-approval lifecycle management, serving as the company's foremost authority on biologics CMC regulatory science. The Senior Director collaborates closely with Process Development, Analytical Sciences, Quality, and external biologics CMOs to ensure that programs are developed, characterized, and submitted in alignment with FDA, EMA, and global Health Authority expectations for biological products. As a senior leader within the Regulatory Affairs organization, this individual also contributes to cross-functional regulatory strategy and plays a foundational role in shaping the company's biologics CMC regulatory infrastructure.

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.

Essential Duties and Responsibilities:

• Develop and lead the CMC regulatory strategy for all biologics assets in the I&I portfolio, from IND/CTA through BLA and MAA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product.
• Author, review, and oversee the preparation of biologics CMC sections of global regulatory submissions in ICH CTD format, including INDs/CTAs, BLAs, MAAs, supplements, and post-approval variations, with accountability for scientific quality, completeness, and regulatory defensibility.
• Serve as the company's primary regulatory authority and strategic partner for biologics Process Development, Upstream and Downstream Manufacturing Sciences, Analytical Development, Formulation, and Quality functions on all CMC regulatory matters.
• Lead Health Authority interactions related to biologics CMC topics, including FDA Type B and Type C meetings (including BPD 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 and EMA biologics CMC guidance documents and ICH Q-series guidelines applicable to large molecules, including ICH Q8, Q9, Q10, Q11, Q12, and Q13, and advise development teams on process characterization, comparability, and control strategy regulatory acceptability.
• Lead post-approval CMC change management strategy for biologics programs, including PACMP development, Prior Approval Supplements (PAS), CBE filings, and EU/global variation submissions related to manufacturing process changes, site changes, and analytical method updates.
• Oversee regulatory aspects of biologics technology transfer activities, including biosimilar comparability assessments, new CMO site qualification, and regulatory filing strategies for site-to-site manufacturing transfers.
• Provide regulatory guidance on biologics-specific CMC considerations, including cell line development, cell banking, upstream and downstream process validation, biophysical and functional characterization, and extended characterization strategies.
• Contribute to regulatory due diligence evaluations of biologics licensing candidates or acquisition targets, assessing CMC regulatory risk, comparability study adequacy, and submission readiness.
• Tracks CMC regulatory deliverables and submission timelines across all biologics 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

Qualifications:

• Education: Advanced degree (PhD, MS, or PharmD) in biochemistry, molecular biology, pharmaceutical sciences, immunology, or a related biologics-relevant discipline strongly preferred or equivalent years of experience.
• Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry
• Deep and comprehensive expertise in biologics CMC regulatory strategy, including cell line development, upstream and downstream process development and validation, biophysical characterization, analytical method validation, and drug product formulation and fill-finish for parenteral biologics.
• Extensive experience authoring and overseeing biologics CMC sections of global regulatory submissions, including INDs/CTAs, BLAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format.
• Demonstrated track record of leading FDA and EMA biologics CMC Health Authority meetings, including BPD (Biologics Product Development) meetings, pre-BLA meetings, and strategic management of CMC deficiency letter responses
• Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12/Q13 guidelines, FDA biologics CMC guidance (including CDER and CBER guidance for therapeutic biologics), and EMA quality guidance applicable to monoclonal antibodies and other biological entities.
• Proven experience managing biologics-specific CMC regulatory challenges, including comparability study strategy, reference standard lifecycle management, specification negotiation, and extended characterization regulatory justification.
• 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.
• Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive regulatory decision-making.