{"id":2787421,"url":"https://alion.io/job/savaglobal-executive-dra","title":"Executive- DRA","company":{"id":4442675,"name":"Savaglobal","domain":"savaglobal.com","url":"https://alion.io/company/savaglobal","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Keka","truth_index":{"grade":"D","score":48,"open_postings":32,"ghost_share":0.875,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Biotech","role_family":"Biotech","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":["Pune, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":400000,"max":484000,"currency":"INR","period":"year","gross":null,"usd_annual":5114},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-07-15T13:02:21Z","employer_posted_date":"2026-07-15","last_verified_at":"2026-10-25T01:55:53Z","board_verified":true,"closed_at":null,"days_open":101,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":101},"description":"Job Purpose\nTo support the Regulatory Affairs function by preparing, compiling, and submitting dossiers for ROW (Rest of World) and EU markets, handling variations, and managing renewals in compliance with applicable regulatory guidelines.\nKey Responsibilities\n1. Dossier Preparation (ROW & EU)\nPreparation and compilation of CTD/eCTD dossiers for ROW and EU markets.\nReview and verification of technical documents (Module 1-5).\nCoordination with QA, QC, Production, R&D, and other departments for required documentation.\nEnsuring submissions comply with guidelines of regulatory authorities such as European Medicines Agency and respective country regulations.\nHandling deficiency queries and preparing responses within stipulated timelines.\n2. Variation Management\nPreparation and submission of variation dossiers (Type IA, IB, Type II as applicable).\nTracking variation approvals and implementation timelines.\nMaintaining updated records of approved variations.\n3. Renewals\nPreparation and submission of renewal dossiers within regulatory timelines.\nCoordination for updated documents required for renewals.\nTracking renewal status and maintaining regulatory database.\n4. Regulatory Compliance & Documentation\nMaintaining regulatory trackers and submission databases.\nEnsuring document archival as per SOPs.\nSupporting audits and inspections related to regulatory documentation.\nEducational Qualification\nB.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)\nExperience\n2-5 years of experience in Regulatory Affairs.\nHands-on experience in ROW and EU dossier preparation.\nExperience in handling variations and renewals.\nKey Skills & Competencies\nStrong knowledge of CTD/eCTD format.\nUnderstanding of EU and ROW regulatory guidelines.\nGood documentation and coordination skills.\nAttention to detail and timeline management.\nProficiency in MS Office and regulatory software tools.","description_format":"text","description_chars":1875,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-17T16:51:48Z"}],"visa":[],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.192,"p_room":0.28,"age_days":100,"expected_fill_days":24,"reasons":["conf:3","stale_co","ghost","win:tail","crowd:junior"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":5114,"is_top_pay":false},"html_url":"https://alion.io/job/savaglobal-executive-dra","json_url":"https://alion.io/job/savaglobal-executive-dra.json","meta":{"generated_at":"2026-10-25T05:39:51Z","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":7870,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":4442675},"rest":"https://alion.io/mcp/rest/get_company?id=4442675"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsavaglobal-executive-dra"},{"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%2Fsavaglobal-executive-dra"},{"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%2Fsavaglobal-executive-dra"},{"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/savaglobal-executive-dra\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsavaglobal-executive-dra"}]}