Regulatory Affairs Senior Associate

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, 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
  
  

Requirements:

• 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
  
  

Compensation

The estimate full-time salary range for this role is between $106,000 to $130,000. 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.

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