Director, CMC Regulatory Affairs

Reporting to the SVP, Head of Regulatory Affairs, the Director of CMC Regulatory Affairs will be responsible for leading Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for products in the development pipeline. This role will work independently to provide strategic leadership on global regulatory submissions and ensure compliance with evolving regulatory requirements. The individual will work cross-functionally with CMC, Quality, Supply Chain, Clinical, and Project Teams to support product development, registration, and lifecycle management.

Please note this is a full-time onsite opportunity

Responsibilities: 

• Regulatory Strategy
• Develop and implement global CMC regulatory strategies to support development, approval, and maintenance of assigned future products.
• Provide expert regulatory guidance for CMC aspects of investigational, registration, and post-approval submission (INDs, IMPDs, NDAs, BLAs, MAAs, supplements/variations, and amendments).
• Monitor evolving global CMC regulations, guidelines, and industry trends, and assess impact on company products.
• Submission & Compliance
• Oversee preparation, review, and submission of high-quality CMC sections for regulatory submissions in the U.S., EU, UK, and other regions.
• Ensure submissions are accurate, complete, and aligned with current regulatory expectations.
• Serve as primary Health Authority contact for CMC-related questions, inspections, and meetings.
• Lead teams in preparations of responses to Health Authority inquiries; through cross-functional collaboration lead the development, review, approval, and submission of response documents.
• Develop strategies and lead teams in preparation to milestone CMC meetings with Health Authorities, including meeting request/briefing document development, meeting rehearsals and conduct of the meetings.
• Oversee and/or personally execute Regulatory Operations responsibilities, including dossier preparation, QC, publishing and proper archiving of submissions, Health Authority correspondence, and commitments.
• Cross-Functional Leadership
• Partner with the CMC and Quality teams to ensure robust regulatory strategies.
• Influence CMC development plans, manufacturing strategies, and lifecycle management decisions.
• Gather regulatory intelligence and seek opportunities to influence external regulatory environment and health policy through collaborations with industry groups and providing company positions on guidance and policy documents related to CMC.
• Represent Regulatory Affairs – CMC in project governance.

Qualifications:

• BS degree or equivalent in Chemistry, Pharmacy, Biology, Engineering, or related field (advanced degree is strongly preferred).
• 10+ years of experience in the biopharmaceutical industry working within a CMC/QA organization, with at least 6 years of direct experience in Regulatory Affairs – CMC.
• Proven track record leading global regulatory CMC strategies across different stages of product development.
• Experience interacting directly with FDA, EMA, and other Health Authorities; experience leading formal Health Authority meetings is strongly preferred.
• In-depth knowledge of FDA, EMA, MHRA, and ICH CMC regulatory requirements; experience with global IND/CTA submissions is required; experience with global marketing authorization submissions is highly desirable (NDA, MAA, etc.).
• Experience operating in a small or start-up biotech environment, with a hands-on and collaborative approach.
• Strong leadership, communication, and problem-solving skills.
• Experience in small molecules, ASOs, and RNA modalities (experience with siRNA is strongly preferred).
• Ability to anticipate and address regulatory challenges proactively.
• Ability to manage multiple priorities in a fast-paced environment.

Competencies:

• Demonstrated ability to influence cross-functional teams and senior leadership.
• Hands-on, resourceful, results-oriented individual who is ready to roll up their sleeves and get the job done despite resource constraints or timeline pressures.
• Strong project management and organizational skills.
• Excellent interpersonal skills

City Therapeutics is accepting resumes/CVs from direct applicants only.  Recruitment Agency inquiries or submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.