{"id":2144024,"url":"https://alion.io/job/itcss-director-regulatory-strategy","title":"Director, Regulatory Strategy","company":{"id":678707,"name":"Itcss","domain":"itcss.com","url":"https://alion.io/company/itcss","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":95,"open_postings":8,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":78,"computed_at":"2026-10-12T06:55:09Z"}},"role":"HR","role_family":"HR","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":143000,"max_usd":286000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1020},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T20:33:09Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-13T01:47:25Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"Hi Tarsan! \nThanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better. \n- Your Human Resources Team\nAbout the Role\nThe Director, Regulatory Strategy will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for their assigned projects. Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required. The candidate will also directly provide or oversee pre- and post-approval submissions activities. The candidate should have a good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail, ability to coordinate and prioritize assigned activities according to project goals and strong interpersonal skills, both written and verbal, are desired. The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, PhD or PharmD).\nKey responsibilities of the role:\nProvide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs.\nWork with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements.\nWork in close collaboration with other functional leads to plan, prioritize, supervise and/or conduct project activities.\nProvide interpretation of regulatory authorities’ feedback, policies and guidelines.\nDevelop regulatory strategic plans, either directly or in conjunction with project teams.\nLead or oversee the preparation of regulatory submissions for assigned projects; responsible for quality and timeliness of IND/CTA/NDA/MAA and post-approval submissions.\nWork with cross-functional partners and contractors in the preparation, review, and completion of documents for regulatory submissions.\nProvide strategic leadership and development to other regulatory strategists to ensure innovative, robust, fit-for-phase regulatory strategies for from FIH to approval.\nProvide regulatory strategy leadership for business development and due diligence, including assessment of asset, risk identification and mitigation, precedent leverage, regulatory probability of success\nEstablish best practices across Regulatory Affairs and other R&D functions to ensure consistent, high-quality execution\nFollow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures.\nAdvance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.\nFactors for Success:\nThe candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, Ph.D. or Pharm D.).\nExcellent verbal and written communication skills.\nCritical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams.\nAbility to thrive in a fast-paced, entrepreneurial environment.\nAbility to function at a high level in a team setting or acting as an individual contributor.\nAn excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.\nA high attention to detail and ability to coordinate and prioritize assigned projects.\nDecision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.\nCollaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.\nOutcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met. \nA Few Other Details Worth Mentioning:\nThe position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.\nWe are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!\nThis position reports directly to our VP, Regulatory Affairs.\nSome travel may be required - up to 10%.\nAt Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. 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