Associate Director, Regulatory CMC

PepGen, Inc.; Massachusetts; Hybrid; USD 148,000 - 220,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health insurance

Life insurance

Disability Insurance

Paid time off

Parental leave

401(k) plan

Cell phone reimbursement

Student loan repayment

529 contributions

Lifestyle spending account

Job summary

PepGen is seeking an experienced Associate Director of Regulatory Affairs CMC to lead global regulatory CMC activities, develop strategies, and guide cross-functional teams through clinical development and late-stage readiness.

Reporting to the Executive Director, this hybrid role requires strong technical expertise, regulatory judgment, and collaboration across CDMOs and CROs to ensure timely submissions and compliant CMC content.

Qualifications

• 8+ years in pharma/biotech with at least 5 years Regulatory CMC experience.
• Experience leading global regulatory CMC activities and submissions for clinical-stage products.
• Involvement in NDA/Module 3 strategy and CMC documentation.
• Strong understanding of drug substance/product development and control strategies.

Responsibilities

• Lead global regulatory CMC strategies for assigned development activities.
• Evaluate development plans, manufacturing processes, analytics, and control strategies for regulatory needs and risks.
• Independently plan and coordinate CMC content for INDs, CTAs, IMPDs, and regulatory amendments.
• Develop regulatory positions and respond to Health Authority questions to support briefing packages.
• Assess impact of manufacturing/analytical changes on regulatory requirements and region filing implications.
• Lead activities supporting technology transfer, process validation, and phase-appropriate controls.
• Contribute to late-stage planning including Module 3 data strategy and gap analysis.
• Coordinate with CROs, CMOs, and Regulatory Operations to ensure timely submissions.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Regulatory judgment

Project management

Education

BSc in Chemistry

Advanced degree (MS/PhD/PharmD)

Job 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.

Reporting 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.

This is a hybrid role, in office Tues-Thurs

Key Responsibilities

• Develop and execute global regulatory CMC strategies for assigned development activities, providing proactive regulatory guidance to CMC, Analytical Development, Quality, and other cross-functional teams.
• Evaluate 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.
• Independently 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.
• Develop regulatory positions and lead preparation of CMC responses to Health Authority questions, contributing to meeting strategies, briefing materials, and regulatory interactions.
• Assess the regulatory impact of manufacturing, analytical, testing, and supply chain changes, including comparability requirements, regional filing implications, and implementation strategies.
• Lead assigned regulatory activities supporting technology transfer, process validation, and the development of phase-appropriate control strategies.
• Contribute to late-stage and registration-readiness planning, including Module 3 content strategy, CMC data requirements, and identification of development or documentation gaps.
• Coordinate with Regulatory Operations, regional regulatory representatives, CROs, and external manufacturing partners to ensure timely submissions and consistency of CMC information across regions.
• Monitor evolving global regulatory requirements, guidance, and precedents, translating relevant developments into practical recommendations for CMC development and regulatory strategy.
• Represent Regulatory CMC on assigned cross-functional teams, independently managing deliverables, communicating regulatory risks and recommendations, and supporting effective decision-making.

Required Qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or related scientific discipline.
• Minimum 8 years of relevant pharmaceutical or biotechnology industry experience, including at least 5 years of direct Regulatory CMC experience.
• Demonstrated experience independently leading global regulatory CMC activities and submissions for clinical-stage pharmaceutical or biotechnology products.
• Demonstrated Regulatory CMC experience in late-stage development and preparation of an NDA, including direct involvement in CMC strategy and Module 3 authoring or review.
• Strong 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.
• Experience assessing manufacturing and analytical changes, comparability requirements, and associated regulatory implications.
• Experience working in an outsourced development and manufacturing model, including collaboration with CDMOs and CROs.
• Working knowledge of FDA, EMA, ICH, and other global regulatory CMC requirements, with experience preparing Health Authority briefing materials and regulatory responses.
• Strong regulatory judgment, communication, and cross-functional leadership skills, with demonstrated ability to independently manage competing priorities and develop scientifically justified recommendations.

Preferred Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in a relevant scientific discipline.
• Experience with oligonucleotides, peptides, conjugated therapeutics, or other complex or emerging modalities.
• Experience with sterile injectable drug products.
• Regulatory CMC experience in APAC regions.
• Experience working in a small or mid-sized biotechnology company with a lean Regulatory Affairs organization.

Compensation

The 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.

PepGen 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.

About PepGen

PepGen 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.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

EEO Statement

PepGen 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.

Recruitment & Staffing Agencies

PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.

E-Verify

PepGen is an E-Verify Employer. For more information about E-Verify, please see here .

Will you require sponsorship now or in the future?

Are you able to come onsite Tuesday-Thursday on a weekly basis?