{"id":1310251,"url":"https://alion.io/job/replimune-sr-manager-regulatory-operations-publishing","title":"Sr. Manager, Regulatory Operations (Publishing)","company":{"id":2285234,"name":"Replimune","domain":"replimune.com","url":"https://alion.io/company/replimune","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"HR","role_family":"HR","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Woburn, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":137500,"max":168500,"currency":"USD","period":"year","gross":null,"usd_annual":168500},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Ignite","optional":false},{"name":"PyTorch","optional":true}],"status":"live","first_seen_at":"2026-09-24T20:01:16Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-12T11:14:46Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"Overview\nReplimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care becausepatient’s lives depend on it.\nAt Replimune, we live by our values:\nUnited: We Collaborate for a Common Goal.\nAudacious: We Are Bold.\nDedicated: We Give Our Full Commitment.\nCandid: We Are Honest With Each Other.\nPeople are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.\nJoin us, as we reshape the future.\nJob Summary\nWe are seeking an experienced Senior Manager, Global Regulatory Submission Management and Publishing to lead the planning, preparation, publishing, quality control, and submission of global regulatory dossiers. This role is a key member of the Regulatory Operations team and will partner closely with Regulatory Affairs, Medical Writing, Clinical Operations, Biostatistics, Data Management, Quality, and external service providers to ensure the successful delivery of high-quality, compliant submissions to global health authorities.\nThe successful candidate will possess extensive expertise in regulatory submission management, eCTD publishing, and global regulatory requirements. This individual will provide technical leadership across submission programs, mentor team members, drive operational excellence, and contribute to the development and continuous improvement of submission processes, standards, and technologies.\nThis position is based in our Woburn office and welcomes remote work, with an expectation of approximately 10% onsite attendance (e.g., annual company-wide meetings and key business events).\nKey Responsibilities\nRegulatory Submission Management\n· Lead the planning, coordination, preparation, publishing, validation, and submission of global regulatory dossiers.\n· Partner with Regulatory Operations Leads and Regulatory Strategy Leads to ensure the timely delivery of compliant submissions to global health authorities.\n· Serve as the Regulatory Operations lead and primary point of contact for assigned submission programs and major regulatory milestones.\n· Provide regulatory operations expertise to cross-functional teams throughout submission planning, preparation, execution, and archiving activities.\n· Manage submission timelines, deliverables, risks, and communication with internal stakeholders and external vendors.\nRegulatory Publishing\n· Compile, publish, validate, and transmit regulatory submissions in accordance with global health authority requirements and electronic submission standards.\n· Lead publishing activities for INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, annual reports, and other global regulatory submissions.\n· Manage submission transmissions through applicable health authority gateways and portals.\n· Ensure submission dossiers are technically valid and compliant with applicable regulatory guidance and organizational standards.\n· Perform publication quality control and verification activities to support first-time-right submissions.\nVeeva Vault RIM Administration and Publishing\n· Serve as a subject matter expert for Veeva Vault RIM Submissions and Publishing.\n· Manage dossier planning, content planning, submission assembly, continuous publishing, validation, and submission activities within Veeva Vault RIM.\n· Support system optimization, process improvements, and implementation of best practices related to regulatory submissions management and publishing.\nProcess Improvement and Compliance\n· Develop, implement, and continuously improve processes, standards, templates, and procedures related to regulatory publishing and submission management.\n· Monitor evolving global regulatory submission requirements and ensure organizational compliance with applicable regulations and guidance.\n· Support inspection readiness activities and contribute to audit responses related to regulatory submissions and electronic records.\n· Identify opportunities for automation and operational efficiencies within Regulatory Operations.\nLeadership and Team Development\n· Provide leadership, mentoring, and technical guidance to publishing and submission management team members.\n· Support knowledge sharing and training initiatives to promote consistency, quality, and operational excellence.\n· Collaborate effectively across global cross-functional teams and external partners to achieve project objectives.\n· Contribute to departmental initiatives and strategic goals that enhance Regulatory Operations capabilities.\nEducational Requirements\nBachelor's degree (BA/BS) or equivalent combination of education and relevant experience required.\nExperience and Skill Requirements\n· Minimum 8 years of Regulatory Operations and Regulatory Publishing experience within the biotechnology, pharmaceutical, or related industry.\n· Demonstrated experience leading complex global regulatory submissions from planning through delivery.\n· Strong knowledge of global regulatory requirements and health authority expectations, including FDA, EMA, MHRA, ICH, and other applicable regions.\n· Extensive experience leading submissions such as INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, and annual reports.\n· Experience working with SEND datasets and regulatory submission datasets.\n· Expert-level knowledge of Veeva Vault RIM Submissions and Veeva Vault RIM Publishing is required.\n· Demonstrated hands-on experience preparing, publishing, validating, and transmitting submissions using Veeva Vault RIM.\n· Experience with electronic submission standards and formats, including eCTD and CTIS.\n· Knowledge of regulatory publishing tools such as DXC, eCTD Xpress, ISI Toolbox, Lorenz, or equivalent platforms.\n· Experience with StartingPoint tools and templates preferred.\n· Strong technical, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.\n· Excellent project management, organizational, and stakeholder management skills.\n· Demonstrated ability to consistently deliver high-quality, compliant submissions while meeting aggressive timelines.\n· Strong written and verbal communication skills.\n· Highly motivated, detail-oriented team player with a collaborative and positive approach.\n· Experience with Veeva PromoMats is preferred.\nSalary Range\nReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $137,500-168,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.\nAt Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.\nAbout Replimune\nReplimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.\nWe are an Equal Opportunity Employer.","description_format":"text","description_chars":8491,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Flexible time off","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T15:39:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"green card filings: 4","filings_12m":0,"filings_prev_12m":12,"green_card_filings_12m":4,"median_offered_wage_usd":122500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":0.9,"age_days":17,"expected_fill_days":42,"reasons":["conf:2","velocity","win:mid"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":168500,"is_top_pay":true},"html_url":"https://alion.io/job/replimune-sr-manager-regulatory-operations-publishing","json_url":"https://alion.io/job/replimune-sr-manager-regulatory-operations-publishing.json","meta":{"generated_at":"2026-10-12T15:51:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25108,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2285234},"rest":"https://alion.io/mcp/rest/get_company?id=2285234"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Freplimune-sr-manager-regulatory-operations-publishing"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Freplimune-sr-manager-regulatory-operations-publishing"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Freplimune-sr-manager-regulatory-operations-publishing"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/replimune-sr-manager-regulatory-operations-publishing\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Freplimune-sr-manager-regulatory-operations-publishing"}]}