Parabilis Medicines

Lead strategy, infrastructure, and execution for all regulatory submissions, ensuring compliance and operational excellence. | Extensive experience in regulatory submissions, expertise in eCTD and RIM systems, leadership skills, and knowledge of global regulatory guidelines. | Why Join Us? Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. What's the opportunity? The Associate Director of Regulatory Operations will lead strategy, infrastructure, and execution for all regulatory submissions (INDs, CTAs, NDAs), ensuring timely, compliant filings with health authorities (FDA, EMA, APAC HAs) by managing teams, processes, systems (eCTD) and cross-functional collaboration, while staying ahead of changing global regulations and driving operational excellence for growth. This position reports to the Senior Director, Regulatory Affairs and will interact with cross-functional teams, including Clinical Operations, Clinical Development, Biostatistics, Nonclinical Science, and Project Management. Key Responsibilities • Strategy & Leadership:Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs. • Submission Management:Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments. • Infrastructure: Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates. • Process Improvement:Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations. • Cross-Functional Collaboration:Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development. • Regulatory Intelligence:Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments. • Vendor Management: Oversee relationships with external vendors and contractors for systems and technology. What you'll need to be successful: • Bachelor's degree or equivalent experience • 8-10+ years industry experience • Expertise in electronic submission standards (eCTD) and regulatory information management (RIM) systems. • Strong leadership, communication, and problem-solving skills. • Ability to manage complex projects, priorities, and budgets. • Deep knowledge of applicable FDA, EMA, and other relevant health authority guidelines • Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus Core Values Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit. • Growth-Minded. We're inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable. • In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. • Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact. • All-In. We're All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history. The base salary range for this position is $165,000-$200,000 per year, depending on experience, qualifications, and internal practices. Parabilis's total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees' overall well-being. As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. 30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com

Oversee safety reporting activities, manage CRO relationships, ensure compliance with global regulations, and participate in safety governance. | Requires a master's in healthcare, 10+ years in pharmacovigilance, leadership experience, and knowledge of global safety regulations and databases. | Job Description: • Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs). • Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. • Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants. • Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators. • Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance. • Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants. • Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness. • Support development and maintenance of internal PV policies, SOPs, and training programs. • Participate in safety signal detection activities and safety governance committees, as needed. • Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events. • Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations. Requirements: • Master’s degree or higher in a healthcare field. • 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role. • Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight. • Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements. • Experience with oversight of drug safety databases (e.g., Oracle Argus). • Proven track record of ensuring compliance in a global PV environment. Benefits: • an annual target bonus • equity • a comprehensive suite of competitive benefits designed to support our employees’ overall well-being