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.

• Oversee safe handling and storage of lithium batteries • Ensure compliance with international and domestic regulations • Develop and deliver training for warehouse staff • Conduct regular safety audits

Trade Compliance Specialist - Remote 176781BR 26677 Agoura Road Calabasas CA Job Description The Trade Compliance Specialist is responsible for pre-importation reviews and post-importation audits/actions for applicable regulatory requirements and associated tariffs as well as risk and cost mitigation, thereof. The role reports to the Manager Trade Compliance Manger in the Imports Department and will work closely with Import Operations, Corporate Social Responsibility, Global Sourcing, Product Compliance, Quality Assurance, Legal, Accounting, Security, and Transportation to ensure compliance to all applicable rules and regulations of imported product as well as supply chain security and UFLPA guidelines.  May involve travel, domestic & international. Duties and Responsibilities - Provide compliance guidance and support while mitigating risks and costs for all aspects of Imports including, but not limited to, product classification, country of origin determination, trade agreements, marking, labeling (product and packaging), antidumping procedures/cases, other government agency requirements, and transportation requirements in accordance to Code of Federal Regulations and all other applicable rules and regulations   - Maintain accuracy, completeness, and alignment of product-related import data in all systems  - Perform audits and assess internal procedures and systems to maintain status in the CTPAT Trade Compliance program (formerly known as Importer Self-Assessment) - Execute, monitor, and report annually on global security initiatives for Customs Trade Partnership Against Terrorism program - Provide support for Import Operations and all CBP as well as PGA transactions - Initiate reconciliation of entry discrepancies, PSCs as necessary and prepare/submit protests as required - Request U.S. Customs binding rulings and prepare Department of Commerce scope inquiries - Keep updated on all U.S. Customs and other government agency compliance changes in regulations - Maintain and develop other compliance tracking tools and documented procedures - Read, analyze and interpret complex documents - Additional duties as assigned Scope (Required) - Supervises staff – None - Financial Scope – Action taken effect duties/tariffs paid - Organizational Scope – As part of the Global Sourcing Division, will need to work closely with the rest of Global Sourcing, as well as Product Compliance, Quality Assurance, Legal, Costing, Security, and Transportation - Decision Making – Decisions made as a team with input from other Trade Compliance Specialists - Travel – Domestic and international travel may be required. The anticipated salary range for this position is $69,500– $104,200 depending on location, knowledge, skills, education and experience. This position is also eligible for an annual discretionary bonus. In addition, we offer comprehensive and competitive benefits to Associates (and their families) such as medical, dental, vision, life insurance, short-term and long-term disability. Eligible Associates are able to enroll in our company’s 401k plan. Associates will accrue paid time off up to 236 hours per year (inclusive of PTO, floating holidays, and paid holidays). Paid sick time up to 80 hours per year unless otherwise required by law. Requirements Job Qualifications – Education and Experience (Required) - Bachelor’s degree in International Relations, International Business, or other related studies highly preferred - Customs broker license - Minimum 3-5 years experience with customs house broker and/or importer (experience with both is preferred) - Must have strong working knowledge of HTSUS, CFRs, CBP directives and bulletins - Understanding of the import process from point of origin, shipping, entry and post entry processes and procedures - Proficiency utilizing spreadsheets to analyze large data sets - Effective communication, verbal and written Physical Requirements General office environment requiring ability to: - stand, walk, sit for extended periods of time - speak and listen to others in person and over the phone - use keyboard and read from computer screen and reports - lift up to 45 lbs. About Harbor Freight Tools We’re a 45 year-old, $8 billion national tool retailer with the energy, enthusiasm, and growth potential of a start-up. We have over 1,600 stores in 48 states across the country and are opening several new locations every week. We offer our customers more than 7,000 tools and accessories, from hand tools and generators to air and power tools, from shop equipment to automotive tools. We provide our customers with the right tool for the right job at the right price, always delivering quality and value.