{"id":3875364,"url":"https://alion.io/job/pepgen-associate-director-regulatory-cmc","title":"Associate Director, Regulatory CMC","company":{"id":3862562,"name":"PepGen","domain":"pepgen.com","url":"https://alion.io/company/pepgen","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":148000,"max":220000,"currency":"USD","period":"year","gross":null,"usd_annual":220000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-06T16:06:50Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-14T14:38:59Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"PepGen is seeking an experienced Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC), to contribute to the development of our novel Enhanced Delivery Oligonucleotide (EDO) therapeutics for neuromuscular and neurological diseases.\nReporting to the Executive Director, Regulatory Affairs CMC, this individual will independently lead assigned global Regulatory CMC activities, develop and execute regulatory strategies, and provide scientific and regulatory guidance throughout clinical development and late-stage readiness. The role requires strong technical expertise, sound regulatory judgment, and the ability to work effectively across functions in a dynamic, clinical-stage biotechnology environment.\nThis is a hybrid role, in office Tues-Thurs\nKey Responsibilities\nDevelop and execute global regulatory CMC strategies for assigned development activities, providing proactive regulatory guidance to CMC, Analytical Development, Quality, and other cross-functional teams.\nEvaluate drug substance and drug product development plans, manufacturing processes, analytical methods, specifications, impurity control, stability, and control strategies to identify regulatory requirements, risks, and potential mitigation strategies.\nIndependently lead the planning, authoring, review, and coordination of CMC content for global regulatory submissions, including INDs, CTAs, IMPDs, amendments, annual reports, and Health Authority briefing packages.\nDevelop regulatory positions and lead preparation of CMC responses to Health Authority questions, contributing to meeting strategies, briefing materials, and regulatory interactions.\nAssess the regulatory impact of manufacturing, analytical, testing, and supply chain changes, including comparability requirements, regional filing implications, and implementation strategies.\nLead assigned regulatory activities supporting technology transfer, process validation, and the development of phase-appropriate control strategies.\nContribute to late-stage and registration-readiness planning, including Module 3 content strategy, CMC data requirements, and identification of development or documentation gaps.\nCoordinate with Regulatory Operations, regional regulatory representatives, CROs, and external manufacturing partners to ensure timely submissions and consistency of CMC information across regions.\nMonitor evolving global regulatory requirements, guidance, and precedents, translating relevant developments into practical recommendations for CMC development and regulatory strategy.\nRepresent Regulatory CMC on assigned cross-functional teams, independently managing deliverables, communicating regulatory risks and recommendations, and supporting effective decision-making.\nRequired QualificationsBachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or related scientific discipline.\nMinimum 8 years of relevant pharmaceutical or biotechnology industry experience, including at least 5 years of direct Regulatory CMC experience.\nDemonstrated experience independently leading global regulatory CMC activities and submissions for clinical-stage pharmaceutical or biotechnology products.\nDemonstrated Regulatory CMC experience in late-stage development and preparation of an NDA, including direct involvement in CMC strategy and Module 3 authoring or review.\nStrong technical understanding of drug substance and drug product development, manufacturing processes, analytical development, specifications, stability, and control strategies, with the ability to critically evaluate underlying scientific and technical data.\nExperience assessing manufacturing and analytical changes, comparability requirements, and associated regulatory implications.\nExperience working in an outsourced development and manufacturing model, including collaboration with CDMOs and CROs.\nWorking knowledge of FDA, EMA, ICH, and other global regulatory CMC requirements, with experience preparing Health Authority briefing materials and regulatory responses.\nStrong regulatory judgment, communication, and cross-functional leadership skills, with demonstrated ability to independently manage competing priorities and develop scientifically justified recommendations.\n Preferred QualificationsAdvanced degree (MS, PhD, PharmD, or equivalent) in a relevant scientific discipline.\nExperience with oligonucleotides, peptides, conjugated therapeutics, or other complex or emerging modalities.\nExperience with sterile injectable drug products.\nRegulatory CMC experience in APAC regions.\nExperience working in a small or mid-sized biotechnology company with a lean Regulatory Affairs organization.\n CompensationThe estimate full-time salary range for this role is between $148,000 to $220,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.\nPepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.\nAbout PepGen\nPepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.\nFor more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.\nEEO Statement\nPepGen is an Equal Opportunity 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.\nRecruitment & Staffing Agencies\nPepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.\nE-Verify\nPepGen is an E-Verify Employer. 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