{"id":3331678,"url":"https://alion.io/job/baxter-sr-specialist-regulatory-affairs","title":"Sr Specialist - Regulatory Affairs","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":93,"open_postings":37,"ghost_share":0,"stale_share":0.432,"repost_share":0.054,"time_to_fill_p50_days":17,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Biotech","role_family":"Biotech","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":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":20000,"max_usd":42000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-10-27T12:19:52Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-10T16:10:04Z","board_verified":false,"closed_at":"2026-11-10T16:10:04Z","days_open":14,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":14},"description":"This is where your work makes a difference.\nAt Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.\nOur Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.\nHere, you will find more than just a job-you will find purpose and pride.\nYour Role at Baxter:\nThis role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.\nWhat you'll be doing:\nReview and provide regulatory impact assessments for changes\nSupport global submission deliverables for product variation submissions\nResponsible for working with other parts of the regulatory organization to achieve desired results.\nExecute global plans and regulatory submission deliverables for sustaining variations\nUtilize regulatory knowledge to prepare submission deliverables that will achieve desired results\nEnsure identified standards and content requirements are met for regulatory submissions\nTimely, actively support query responses\nEngage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements\nInterface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).\nMaintain regulatory files in a format consistent with requirements\nTracking of status, quality/compliance and progress of regulatory documentation\nReview, edit and proofread regulatory documentation\nWhat you'll bring: \nMaster's Degree or country equivalent in related scientific discipline\nHigher degree/PhD will be an advantage, 7+ years’ regulatory experience in RA or related healthcare environment\nExperience in Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance.\nExperience in CMC regulatory authoring, including preparation and review of CTD Module 3 documentation and supporting global regulatory submissions throughout the product lifecycle.\nExperience operating in a regulated environment\nAbility to operate in a matrixed environment and manage multiple activities, priorities and deadlines\nExercise independent judgement\nScientific knowledge and ability to discuss technical matters with cross-functional team members\nKnowledge of regulations and ability to communicate and apply\nAbility to identify compliance risks and escalate when necessary\nExcellent verbal and written English communication skills, suitable for multi-location working relationships\nDemonstrated teamwork and collaboration skills\nAptitude for Attention to Detail\nEqual Employment Opportunity\nBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\nReasonable Accommodations\nBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.\nRecruitment Fraud Notice\nBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.","description_format":"text","description_chars":4376,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Patient Monitoring","Hospital Equipment & Furniture","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-27T12:19:52Z"},{"event":"close","at":"2026-11-10T16:10:04Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/baxter-sr-specialist-regulatory-affairs","json_url":"https://alion.io/job/baxter-sr-specialist-regulatory-affairs.json","meta":{"generated_at":"2026-11-13T22:37:39Z","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":45060,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":5835},"rest":"https://alion.io/mcp/rest/get_company?id=5835"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbaxter-sr-specialist-regulatory-affairs"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fbaxter-sr-specialist-regulatory-affairs"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fbaxter-sr-specialist-regulatory-affairs"},{"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/baxter-sr-specialist-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-sr-specialist-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3331678}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3331678},"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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