Regulatory Affairs Co-op

Company: OSI
Location: Boston
Posted on: February 18, 2025

Job Description:

The Co-op will support key aspects of regulatory to support the development of PepGen's clinical stage novel peptide-oligonucleotide conjugate therapeutics for a range of neuromuscular and neurologic indications. In this hands-on regulatory position, the successful candidate will work closely with the Global Regulatory and Medical Writing team and gain exposure and experience in how to develop a global regulatory strategy, including submissions, regulatory compliance, and the understanding and application of guidance and requirements for multiple geographies (including the USA and Canada, and beyond).Responsibilities:

• With the wider teams develop planning, logistics, and document development for regulatory agency submissions and interactions including CTA submissions, development of query responses documents, briefing documents for agency interactions and other general regulatory agency submissions.
• 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 of regulatory processes for submission planning and management, and oversight of regulatory requirements.Requirements:
• BS or MS in Biology, Pharmaceutical Sciences, or a closely related field.
• Must have excellent interpersonal, written and verbal communication skills, and administrative skills.
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel, and Project.
• Ability to work onsite Tuesday - Thursday from 9am to 5pm in the Boston office.About PepGenPepGen Inc. 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, or 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 that target the root cause of serious diseases. For more information, visit or follow PepGen on and .EEO StatementPepGen 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 AgenciesPepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you.
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Keywords: OSI, Boston , Regulatory Affairs Co-op, Other , Boston, Massachusetts