{"id":3587869,"url":"https://alion.io/job/lifelancer-regulatory-operations-expert","title":"Regulatory Operations Expert","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["IN"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":109000,"max_usd":198000,"period":"year","method":"global_role_seniority_cell","sample_n":543},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"ICH Guidelines","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-01T13:16:12Z","employer_posted_date":null,"last_verified_at":"2026-11-01T13:16:12Z","board_verified":false,"closed_at":null,"days_open":0,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":0},"description":"Job Title: Regulatory Operations Expert\nJob Location: Mumbai\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: \nJob Overview:\nScientific Writer with strong expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecycle management.\nThis role serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle ready CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing.\nYou work at the interface of science, manufacturing, quality, and regulatory, ensuring that how we understand materials and processes is clearly articulated, justified, and sustained throughout the product lifecycle\nSummary of Responsibilities:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.\nScientific Leadership & CMC Knowledge Translation\nAct as a scientific owner for the development of high‑quality CMC documentation related to:\nPharmaceutical raw materials and excipients\n\nProcess aids and contact materials (incl. leachables & extractables)\n\nMaterial changes, supplier changes, and lifecycle optimization activities\n\nTranslate complex analytical, chemical, and manufacturing data into:\nScientifically rigorous justifications\n\nRisk assessments and material qualification reports\n\nCMC sections supporting variations, supplements, and regulatory responses\n\nEnsure scientific content is aligned with Quality‑by‑Design principles and clearly supports:\nControl strategies\n\nDefined design space and material attribute justifications\n\nLifecycle change management\n\nAnalytical Chemistry & Chemical Understanding\nIntegrate and critically interpret analytical chemistry data, including:\nPhysicochemical characterization\n\nImpurity and degradation profiles\n\nElemental and inorganic contaminants\n\nComparability and trend analyses\n\nApply organic and inorganic chemistry principles to:\nAssess material composition, chemical reactivity, and degradation pathways\n\nEvaluate compatibility with formulations, processes, and packaging systems\n\nSupport scientifically sound impurity and risk justifications\n\nIdentify analytical data gaps and define scientifically appropriate strategies to close them, in collaboration with analytical development and external laboratories.\n\nManufacturing Processes, Unit Operations & MSAT Lifecycle Support\n\nProvide scientific assessments on the impact of material attributes on pharmaceutical manufacturing processes and unit operations, including:\nBlending, granulation, drying, compression, coating\n\nMixing, filtration, emulsification, sterilization (as applicable)\n\nSupport technology transfer, PPQ, and commercial manufacturing by:\nDocumenting material‑process interactions\n\nSupporting root cause investigations and comparability assessments\n\nProviding scientific rationales for process or material changes\n\nEnsure scientific conclusions reflect manufacturing reality, robustness, and process capability, not only laboratory observations.\n\nLifecycle Management, Compliance & Regulatory Alignment\n\nEnsure documentation is fully aligned with global regulatory and compliance expectations, including:\nICH Q8–Q12 principles\n\nPharmacopeial requirements\n\nGMP expectations for materials, suppliers, and change management\n\nSupport regulatory submissions, variations, and health authority interactions by:\nProviding clear, defensible scientific rationales\n\nEnsuring consistency between analytical data, process understanding, and CMC narratives\n\nMaintain strong traceability between experimental data, conclusions, and regulatory positions throughout the product lifecycle.\n\nCross‑Functional Scientific Collaboration\nAct as a scientific interface between MSAT, Analytical Development, Formulation, Manufacturing, Quality, and Regulatory Affairs.\n\nEngage with external suppliers, contract laboratories, and technical experts to:\nClarify chemistry‑ and material‑related questions\n\nChallenge data quality where needed\n\nEnsure completeness and scientific credibility of external information\n\nContribute actively to knowledge management within MSAT by ensuring scientific learnings are captured in a reusable, lifecycle‑oriented manner.\n\nQualifications (Minimum Required):\nBachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable. “Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.” OR\n\nAdvanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences\n\nInnovation and Proactive, taking ownership, Precise, Goal oriented.\n\nLeadership, problem solving, interpersonal skills.\n\nTechnical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.\n\nGood understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable Years of experience in the job discipline.\n\nGood organizational and time management ability\n\nGood analytical capabilities and Customer focus\n\nGood review skills and concern for quality\n\nCapabilities to face internal and external Audit situation\n\nExcellent command of written and spoken English and/or other languages as applicable\n\nExperience (Minimum Required): \nAt least 7-9 years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical Science / Packaging, polymer and/or Pharmaceutics / material management, Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences and overall drug development and manufacturing process\n\nMinimum 1+ year of experience in project management is desirable.\n\nStrong, hands on scientific understanding of:\n\nAnalytical chemistry and material characterization\n\nOrganic and inorganic chemistry relevant to pharmaceutical materials\n\nPharmaceutical manufacturing processes and unit operations\n\nDemonstrated experience in CMC relevant scientific documentation, including:\n\nMaterial qualification and risk assessments\n\nComparability and lifecycle justifications\n\nRegulatory facing scientific narratives\n\nAbility to independently analyze complex datasets, draw defensible conclusions, and clearly articulate scientific rationale.\n\nFamiliar with pharmaceutical compliance, including GMP expectations for materials, suppliers, and lifecycle change control.\n\nPreferred Qualifications Include: \nBachelor’s in pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 7-9 years of relevant experience. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR\n\nAdvanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences\n\nKnowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred\n\nDiploma or Certification in Regulatory Affairs will be preferred\n\nInnovation and Proactive, taking ownership, Precise, Goal oriented.\n\nLeadership, problem solving, interpersonal skills.\n\nTechnical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools. \n\nGood understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable Years of experience in the job discipline.\n\nGood organizational and time management ability\n\nGood analytical capabilities and Customer focus\n\nGood review skills and concern for quality\n\nScientist mindset with a strong sense of ownership and accountability for scientific quality.\n\nAnalytical, structured, and rigorous in data interpretation and verification.\n\nProactive and confident in engaging senior scientific, manufacturing, and regulatory stakeholders.\n\nStrong communicator who can convert complex science into globally aligned, regulator ready CMC knowledge.\n\nPhysical Demands / Work Environment: Office/Home-Based:\nWork Environment: \n\nWork is performed in an office environment with exposure to electrical office equipment.\n\nOccasional drives to site locations with occasional travel both domestic and international.\n\nAvailable for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.\n\nPhysical Requirements:\nFrequently stationery for 6-8 hours per day.\n\nRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.\n\nOccasional crouching, stooping, with frequent bending and twisting of upper body and neck.\n\nAbility to access and use a variety of computer software developed both in-house and off-the-shelf.\n\nLight to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.\n\nRegular and consistent attendance.\n\nVaried hours may be required.\n\nLearn more about our EEO & Accommodations request here.\n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":9763,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Internet Services","Job Boards & Aggregators","Healthcare Staffing"],"lifecycle":[{"event":"open","at":"2026-11-01T14:30:45Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":29,"reasons":["seen:0","velocity","win:early","comp:brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/lifelancer-regulatory-operations-expert","json_url":"https://alion.io/job/lifelancer-regulatory-operations-expert.json","meta":{"generated_at":"2026-11-02T12:47:20Z","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":17404,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":3853997},"rest":"https://alion.io/mcp/rest/get_company?id=3853997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifelancer-regulatory-operations-expert"},{"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%2Flifelancer-regulatory-operations-expert"},{"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%2Flifelancer-regulatory-operations-expert"},{"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/lifelancer-regulatory-operations-expert\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifelancer-regulatory-operations-expert"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3587869}},{"tool":"search_jobs","arguments":{"company":"lifelancer.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3587869},"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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