{"id":3315920,"url":"https://alion.io/job/sarepta-manager-global-regulatory-strategy","title":"Manager, Global Regulatory Strategy","company":{"id":1949959,"name":"Sarepta","domain":"sarepta.com","url":"https://alion.io/company/sarepta","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States","Washington, United States","New York, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116000,"max":145000,"currency":"USD","period":"year","gross":null,"usd_annual":145000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-28T18:51:48Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Why Sarepta? Why Now?\nSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne Muscular Dystrophy and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases.\nWe’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.\nWhat Sarepta Offers\nAt Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:\nPhysical and Emotional Wellness\n\nFinancial Wellness\n\nSupport for Caregivers\n\nFor a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us\nThe Importance of the Role\nParticipates in clinical and nonclinical regulatory strategic discussions, supports multiple products’ clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities.This is a US based remote position.\nThe Opportunity to Make a Difference\nActs as the regulatory affairs clinical lead for clinical trial activities, including but not limited to planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.\nReviews of all regulatory agency submission materials for submissions conducted by a CRO on behalf of Sarepta\nImplements regulatory activities in support of product lifecycle activities for assigned markets\nEnsures effective assembly & preparation of country specific submissions\nProvides regulatory support to Global Regulatory Lead in definition & communication of regulatory strategy for assigned markets for assigned products & inputs into project teams via GRT, in support of GRA goals \nContributes to global regulatory strategy and execution and participates in Global Regulatory Teams\nWorks closely with RA CRO to maintain trial progression and compliance\nProvides regulatory guidance, in relation to clinical trial activity, and updates cross- functionally as needed\nEnsures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs\nDevelops and maintains knowledge of relevant evolving regulation and guidance\nWorks on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends\nEscalates and effectively communicates issues to supervisor and other relevant RA stakeholders\nFollows processes and operational policies in selecting methods and techniques for obtaining solutions\nWorks on objectives that have meaningful impact on unit and the organization\nErroneous decisions or failure to execute has medium impact to overall GRA deliverables\nMore about You\nSkills and Competencies\nKnowledge of drug development and regulatory process \nKnowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation \nDemonstrated experience preparing submissions, with and a clear understanding of submission content and format requirements \nAdaptive communication skills (including interpersonal, written, verbal) \nAbility to successfully multi-task, prioritize, manage projects/timelines, and organize/track complex information \nExperience working in cross functional project teams \nSolid sense of accountability and sound judgement; highest ethical standards and focus on quality and details \nProficiency with Microsoft Office Applications; Word, Excel, Outlook, and Adobe Suite systems \nEducation and Experience\nBS or equivalent with 5+ years of relevant experience \nMS in Regulatory Affairs or RAC \nWhat Now?\nWe’re always looking for solution-oriented, critical thinkers.\nSo, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.\n#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $116,000 - $145,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.","description_format":"text","description_chars":5717,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T05:27:59Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":28,"reasons":["seen:2","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":145000,"is_top_pay":false},"html_url":"https://alion.io/job/sarepta-manager-global-regulatory-strategy","json_url":"https://alion.io/job/sarepta-manager-global-regulatory-strategy.json","meta":{"generated_at":"2026-10-29T02:23:57Z","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":3649,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":1949959},"rest":"https://alion.io/mcp/rest/get_company?id=1949959"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsarepta-manager-global-regulatory-strategy"},{"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%2Fsarepta-manager-global-regulatory-strategy"},{"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%2Fsarepta-manager-global-regulatory-strategy"},{"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/sarepta-manager-global-regulatory-strategy\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsarepta-manager-global-regulatory-strategy"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3315920}},{"tool":"search_jobs","arguments":{"company":"sarepta.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3315920},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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