• Support NERC and other applicable regulatory compliance programs for generation assets, including IBR facilities • Track regulatory requirements, deadlines, periodic deliverables, and reporting obligations • Organize, review, and maintain compliance evidence and documentation • Assist with audits, spot checks, RFIs, self-certifications, and other regulatory reviews • Review procedures, technical documents, and internal controls for compliance alignment • Identify potential compliance gaps and support corrective actions and mitigation tracking • Monitor regulatory changes and communicate impacts to internal stakeholders • Support compliance activities related to Generator Owner (GO) and Generator Operator (GOP) responsibilities, as applicable • Assist with implementation and maintenance of compliance obligations associated with generation operations, event response, disturbance reporting, modeling, and emerging IBR-related reliability requirements • Coordinate with operations, engineering, asset management, and regulatory personnel to support ongoing compliance readiness

• Define and lead the privacy and compliance roadmap for entering new global markets, navigating localized data privacy laws, and managing cross-border data transfer requirements. • Take end-to-end ownership of completing enterprise security questionnaires and deeply review/negotiate liability caps, notice periods, and security exhibits in Data Processing Agreements (DPAs) and Business Associate Agreements (BAAs). • Serve as Inato's registered Data Protection Officer (DPO). Own the ongoing governance of GDPR and HIPAA. Manage our Information Security Management System (ISMS) and partner closely with Engineering/IT to maintain our ISO 27001 certification. • Act as the face of Inato’s compliance, leading live security calls with enterprise sponsors and clinical sites to defend our posture. • Act as a consultant to Product Managers, reviewing feature roadmaps and data flows to ensure global patient data management remains compliant from the ideation phase. • Act as the crucial translator who converts complex legal obligations into clear, actionable business requirements and tickets for the engineering team to build. • Create compliance collateral (whitepapers, FAQs) to proactively answer customer questions and implement vendor risk management processes.

Role Description The Executive Director, Regulatory CMC will provide strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. Reporting to the SVP, Regulatory and Medical Writing, this role serves as a liaison to health authorities, driving regulatory strategies, overseeing high-quality submissions, and ensuring compliance with FDA, EMA, and ICH guidelines. The position requires deep expertise in small molecule development, strong cross-functional collaboration, and the ability to influence organizational policies and processes in a fast-paced, growing environment. The ideal candidate combines strategic vision with hands-on leadership to deliver innovative, compliant solutions that accelerate development and commercialization. Key Responsibilities - Provide overall regulatory CMC strategy for drug development programs and life cycle management, ensuring alignment with corporate objectives and timelines. - Serve as a spokesperson and trusted liaison with FDA and other health authorities, leading negotiations and presenting CMC positions effectively. - Develop de-risking strategies for CMC development, assess change controls, and identify opportunities to accelerate development in a dynamic environment. - Lead creation and execution of comprehensive CMC development plans for new products, ensuring integration with Technical Operations and external partners. - Partner with supply chain, clinical operations, and manufacturing teams to ensure readiness and compliance for clinical and commercial supply. - Oversee preparation and quality of all CMC regulatory submissions (INDs, BLAs, MAAs, DMFs, IMPDs, amendments, annual reports), providing strategic direction and ensuring global compliance. - Drive the development and implementation of departmental policies, SOPs, and best practices to support scalability and operational excellence in a growing organization. - Interpret and communicate regulatory CMC requirements and expectations to internal teams and external partners to ensure program objectives are met. - Contribute to corporate initiatives aimed at improving regulatory standards, systems, and processes across the organization. Qualifications - Master’s degree in chemistry, pharmaceutical sciences, or a related scientific field (PharmD or PhD preferred). - Minimum 15 years in the pharmaceutical industry, including at least 7 years in Regulatory CMC. - Demonstrated experience across early-stage, late-stage development, and life cycle management for small molecule products. - Comprehensive understanding of FDA, EMA, and ICH CMC guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP). - Proven experience preparing and submitting CMC regulatory documents (e.g., INDs, IMPDs, CTAs, NDA's, MAAs) and leading successful interactions with health authorities such as FDA and EMA. - Track record of developing and executing CMC regulatory strategies, balancing near-term objectives with long-term goals. - Strong leadership skills with the ability to work effectively in a matrixed environment; excellent verbal and written communication skills to articulate regulatory viewpoints to diverse audiences. - Ability to thrive in a fast-paced, collaborative environment and comfortable with both strategic planning and hands-on execution. Requirements - The annual base salary range for this job level is $285,000 - $350,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. - In addition to base pay, this role is eligible for a discretionary annual bonus. - Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. Work Location - The Executive Director, Regulatory CMC role is a remote role based in the US, with occasional travel. EEOC Statement Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Role Description The Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. - Develop and execute U.S. and global regulatory strategies for one or more solid tumor oncology programs across the clinical development lifecycle, aligned with corporate and program objectives. - Serve as the Regulatory Affairs lead on cross‑functional program teams, providing regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, Quality, and other stakeholders. - Lead the strategic planning, review, and execution of regulatory submissions and maintenance activities (e.g., INDs, CTAs, amendments, briefing packages, and, as applicable, BLAs/MAAs), ensuring compliance with global regulatory requirements. - Assess and pursue oncology-specific expedited programs and designations, including Fast Track, Breakthrough Therapy Designation, Orphan Drug Designation, Accelerated Approval, and EMA PRIME, as appropriate for solid tumor indications. - Lead and coordinate health authority interactions, including meeting strategy, preparation and oversight of briefing documents, responses to requests for information, and management of post‑meeting commitments. - Conduct regulatory risk assessments and gap analyses; identify potential issues and develop mitigation strategies to support successful regulatory outcomes. - Provide regulatory leadership in the assessment of emerging clinical data and operational activities, evaluating regulatory impact and advising on strategy adjustments as needed. - Contribute to and/or lead the development and review of key regulatory documents, including clinical protocols and clinical and nonclinical study reports. - Drive high‑quality execution of regulatory deliverables, including alignment of timelines, content consistency across documents, and adherence to internal standards and best practices. - Translate evolving global regulatory guidance and regulatory intelligence into actionable recommendations for program teams and senior leadership. - Support the growth and scalability of the Regulatory Affairs function through process improvement, cross‑functional alignment, and mentoring of internal team members and external partners, as appropriate. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Qualifications - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 12+ years of regulatory affairs experience in the life sciences industry or an equivalent combination of academic and industry experience. - Direct experience supporting early-stage (pre-IND to Phase 1/2) solid tumor oncology programs. - Familiarity with multiple oncology modalities (e.g., small molecules, biologics, ADCs). - Demonstrated ability to develop, lead, and implement global regulatory strategies for complex development programs across multiple phases of the product lifecycle. - Extensive knowledge of U.S. and international regulatory requirements, including FDA and EMA regulations, guidance, and industry standards applicable to oncology development programs. - Proven experience leading major regulatory submissions and global filing activities (e.g., INDs, CTAs, and, as applicable, BLAs, MAAs, NDAs/NDSs). - Demonstrated success leading regulatory interactions with health authorities, including briefing package development, response strategy, and negotiation of regulatory positions and commitments. - Strong track record of independent decision‑making, regulatory risk identification, and development of mitigation strategies affecting program and portfolio outcomes. - Demonstrated ability to influence and lead cross‑functional teams in a matrix environment, providing strategic regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, and related functions. - Strategic thinker with strong analytical judgment, problem‑solving skills, and the ability to thrive in a fast‑paced, evolving biotech environment. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Benefits - Eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. - Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. - Enrollment in the Company’s 401(k) plan. - Accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. - Enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.