Senior Director, Regulatory Affairs
: Job Details :

Why join us?Parabilis Medicines (formerly FogPharma) is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, Parabilis is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. Parabilis is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. Parabilis Medicines has raised more than $500 million to date from leading life sciences investors. Parabilis is headquartered in Cambridge, Mass.What's the opportunity?The Sr. Director, Regulatory Affairs will be responsible for assisting in the development and implementation of a consolidated regulatory strategy (including regulatory operations) to secure and maintain regulatory approval for the assigned product through all development phases. The Sr. Director is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals with a focus on regulatory submissions.Essential Duties and ResponsibilitiesDefines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory complianceWhen assigned, supervise one or more Regulatory Affairs staff, be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.Ensures global regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategyServe as the primary interface for regulatory agencies on assigned projects.Ensures global project teams are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a timely and effective manner.Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.Prepare company for FDA and other health agency meetings, as required.Oversee vendor responsibility for regulatory activities and submissions related to projects within scopeRepresent Regulatory Affairs on relevant cross-functional teams, including Project Teams, Clinical Teams and Study Teams.Establish regulatory intelligence by maintaining knowledge of global regulatory environment, regulations and guidancesContribute to the development and maintenance of Regulatory Affairs working practices and procedures.Participates in Business Development efforts, as assigned.What you'll need to be successful:Education, Certifications, ExperienceBachelor's degree in scientific discipline; advanced scientific degree preferred10 - 15 + years pharmaceutical industry experience, including 7+ years in Regulatory Affairs leadership roles. Global experience desired.Experience in multiple phases of development particularly oncology desiredDemonstrated experience in preparing global submissions especially NDAs/BLAs for the FDA.Knowledge, Skills and AbilitiesKnowledge of the drug development process and global submission process.Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.Core ValuesParabilis 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.Creative. We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.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.Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.Humble. We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.As an equal opportunity employer, Parabilis Medicines values diversity 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