{"id":2239125,"url":"https://alion.io/job/novartis-associate-global-regulatory-manager-grssc","title":"Associate Global Regulatory Manager, GRSS&C","company":{"id":5824,"name":"Novartis","domain":"novartis.com","url":"https://alion.io/company/novartis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":79,"ghost_share":0,"stale_share":0.646,"repost_share":0.013,"time_to_fill_p50_days":27,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Operations","role_family":"Operations","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":6000,"max_usd":13000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":19},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-11T01:01:17Z","employer_posted_date":"2026-10-11","last_verified_at":"2026-10-31T08:31:47Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"Job Description Summary\nResponsible for managing regulatory clinical trials or maintenance activities under supervision, the aGRM-RACS focuses on the delivery of regulatory activities related to clinical trial applications or to the maintenance of the assigned portfolio for selected countries/region.The aGRM-RACS collaborates with the study team or with the Country lead and the line functions to ensures high quality (complete, well organized, scientifically accurate, compliant) submissions are prepared, reviewed and timely approved.\nJob Description\nKey Responsibilities:\nFor a product portfolio, the aGRM- RACS ensures under supervision that clinical trial applications or maintenance submissions are prepared on time and in compliance with regulatory regulations, guidelines, and in line with Novartis processes and system requirements.\nManage assigned product portfolio and country / region knowledge.\nUse regulatory expertise and knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and achieve timely submission and approvals.\nManage timely responses to HA queries and collaborate with regulatory lead to preparing strong justifications to address regulatory gaps.\nResponsible for appropriate entering of product specific attributes in compliance database and applicable RIMs.\nFacilitate preparation and finalization of documents for HA interactions for matters of low complexity.\n\nContribute to non-project related initiatives focused on productivity, continuous improvement, and automation.\nShare knowledge on specific topics and support other associates within Regulatory Affairs.\nMinimum Requirement\nSciencebased BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.\nRegulatoryaffairs experience of 7 to 10 (at least 5 years of relevant exp) with knowledge of regulations, guidelines and regulatory processes for maintenance activities\nExperienceof regulatory submission and approval processes in major countries.Planning, execution, reporting, regulatory review, compliance and submission experience\nAbilityto participate in process improvements, simplification, automatization and operational excellence initiatives\nUnderstand safety and efficacy data and product labels. Reliable, timely, accurate and proactive communication as appropriate\nBasicorganizational awareness (e.g., interrelationship of departments). Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry\nSkills Desired\nData Analysis, Regulatory Compliance, Waterfall Model","description_format":"text","description_chars":2576,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-11T01:01:17Z"}],"visa":[],"liveness":{"score":43,"band":"fade","label":"Fading","p_open":1,"p_active":0.577,"p_room":0.75,"age_days":20,"expected_fill_days":27,"reasons":["conf:1","stale_co","velocity","win:late","comp:junior,brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/novartis-associate-global-regulatory-manager-grssc","json_url":"https://alion.io/job/novartis-associate-global-regulatory-manager-grssc.json","meta":{"generated_at":"2026-10-31T12:27:21Z","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":19253,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":5824},"rest":"https://alion.io/mcp/rest/get_company?id=5824"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnovartis-associate-global-regulatory-manager-grssc"},{"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%2Fnovartis-associate-global-regulatory-manager-grssc"},{"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%2Fnovartis-associate-global-regulatory-manager-grssc"},{"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/novartis-associate-global-regulatory-manager-grssc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnovartis-associate-global-regulatory-manager-grssc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2239125}},{"tool":"search_jobs","arguments":{"company":"novartis.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2239125},"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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