{"id":4033331,"url":"https://alion.io/job/deciphera-director-regulatory-affairs","title":"Director, Regulatory Affairs","company":{"id":8871,"name":"Deciphera","domain":"deciphera.com","url":"https://alion.io/company/deciphera","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":196000,"max":245000,"currency":"USD","period":"year","gross":null,"usd_annual":245000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-10T18:48:43Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-10T19:20:37Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability-empowering individuals to challenge the unknown together. Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com\n The Director, Regulatory Affairs will join a group of highly motivated regulatory professionals and play a critical role in shaping cohesive regulatory strategies across Deciphera’s product pipeline.\nThe Director will operate as a strategic regulatory lead, developing and implementing global regulatory strategies for oncology programs from early development through post-marketing. This role will provide expert guidance to cross-functional teams, drive regulatory submissions, and ensure compliance with applicable regulations and industry standards.\nKey Responsibilities\nRegulatory Strategy & Leadership\nRegulatory lead for assigned oncology programs, developing and implementing innovative regulatory strategies from FIH through post-marketing stages.\nProvide regulatory input to clinical and development teams to ensure strategic alignment across functions.\nMonitor and interpret global regulatory trends and communicate potential impact on programs to senior leadership.\nRegulatory Submissions & Compliance\nLead the preparation and submission of INDs, NDAs, and other regulatory filings in collaboration with cross-functional teams.\nEnsure all submissions are of high quality, compliant, and meet global regulatory expectations.\nProvide hands-on operational oversight for submission preparation, review, and delivery.\nCross-Functional Collaboration\nPartner with Clinical Development, Clinical Operations, Quality, and CMC teams to ensure regulatory strategy integration across all development activities.\nProvide timely and accurate regulatory advice to project teams and senior management.\nRepresent Regulatory Affairs at internal and external meetings, including interactions with regulatory authorities.\nLeadership & People Management\nProvide guidance and mentorship to Regulatory Affairs staff to enhance departmental capabilities.\nAssess team resources and project priorities to ensure timely delivery of key milestones.\nPromote a collaborative, solutions-oriented culture within the Regulatory Affairs organization.\nProcess Improvement & Innovation\nContribute to continuous improvement initiatives and implement new processes to increase regulatory efficiency.\nLeverage learnings from prior projects to optimize global regulatory submissions and strategies.\nFoster innovation and strategic thinking in regulatory planning and execution.\nOther duties and responsibilities as assigned\n Required Qualifications\nB.S. or M.S. in a scientific discipline and a minimum of 12 years of experience in pharmaceutical Regulatory Affairs.\nAdvanced knowledge and experience interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU.\nProven track record in preparing and submitting INDs, NDAs, and other major regulatory filings.\nExperience engaging with FDA and other global regulatory agencies.\nDemonstrated ability to lead and manage multiple complex projects simultaneously.\nExcellent written, verbal, and interpersonal communication skills.\nPreferred Experience\nStrategic thinker with the ability to anticipate regulatory challenges and propose innovative solutions.\nExperience working in oncology drug development at a small-to-midsize biotechnology company.\nStrong leadership and mentorship skills with a collaborative approach.\nAbility to thrive in a fast-paced, cross-functional environment.\nDetail-oriented, proactive, and results-driven mindset.\n Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $196,000 - $245,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.\nDeciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)\nBenefits:\nCompetitive salary and annual bonus.\nComprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.\nGenerous parental leave and family planning benefits.\nOutstanding culture and opportunities for personal and professional growth.\nApply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!\nEQUAL EMPLOYMENT OPPORTUNITY INFORMATION\nDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.\nEQUAL EMPLOYMENT OPPORTUNITY INFORMATION\nDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. 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