• Assist Regulatory Leads to support regulatory activities (e.g., IND/CTA submissions, agency responses and meetings).
• Work with business partners, external experts, CRO’s and internal colleagues, to coordinate regulatory submissions.
• Create, maintain and archive regulatory documents, agency communications, and regulatory information in the RIM system.
• Support regulatory compliance activities such as planning, tracking, and alignment of contents and timelines for regulatory submissions.
• Collaborate with cross-functional teams to address questions and support responses during agency reviews.
• Assist in drafting or updating regulatory standard operating procedures (SOPs).
• Contribute to clinical trial activities and documentation in line with good clinical practice (GCP) standards.
• Monitor the development of new regulatory requirements or guidance documents to support the Regulator Affairs department and communication of the impact on the business or development program.
• Support Regulatory Intelligence surveillance and interpretation to aid the development of the global regulatory strategy plans to anticipate regulatory obstacles and emerging issues, including changing regulations.
• Support the development and execution of project goals and any ad hoc regulatory activities.

• Bachelor’s degree in a scientific discipline; a relevant advanced degree (e.g., MS, PharmD) is preferred and certification is a plus.
• 2+ years in the pharmaceutical/biotech industry
• Knowledge of FDA regulations, ICH guidelines, and regulatory submission processes.
• Experience with VeevaRIM is preferred
• Ability to understand and communicate scientific/clinical information.
• Ability to collaborate with team members to tackle problems and develop a course of action.
• Ability to prioritize and balance multiple activities with ambiguity in a fast-paced environment.
• Must have excellent interpersonal, written and verbal communication skills, and administrative skills
• Willing to travel for occasional in-person team meetings
• Ability to work onsite Tuesday – Thursday in the Boston office

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.

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