Regulatory Affairs Senior Associate

Role Summary

The Regulatory Senior Associate will support key aspects of regulatory to support the development of PepGen’s novel peptide-oligonucleotide conjugate therapeutics targeting neuromuscular and neurologic indications. In this hands-on regulatory position, the successful candidate will work closely with cross-functional teams to coordinate regulatory submissions, support global regulatory strategy execution, and maintain compliance across all development activities for the lead clinical stage asset, PGN-EDODM1.

Responsibilities

• Assist Regulatory Leads to support regulatory activities (e.g., IND/CTA submissions, agency responses and meetings).
• Work with business partners, external experts, CROs 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 Regulatory 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.

Qualifications

• Required: Bachelor‚Äôs degree in a scientific discipline; a relevant advanced degree (e.g., MS, PharmD) is preferred and certification is a plus.
• Required: 2+ years in the pharmaceutical/biotech industry.
• Required: Knowledge of FDA regulations, ICH guidelines, and regulatory submission processes.
• Preferred: Experience with VeevaRIM.
• Required: Ability to understand and communicate scientific/clinical information.
• Required: Ability to collaborate with team members to tackle problems and develop a course of action.
• Required: Ability to prioritize and balance multiple activities with ambiguity in a fast-paced environment.

Skills

• Excellent interpersonal, written and verbal communication skills; strong administrative capabilities.
• Ability to work with cross-functional teams and internal partners to address regulatory questions.
• Strong organizational and documentation management skills.

Education

• Bachelor‚Äôs degree in a scientific discipline; advanced degree (MS, PharmD) preferred.

Additional Requirements

• Willing to travel for occasional in-person team meetings.
• Ability to work onsite in the Boston office Tuesday‚ÄìThursday.