{"id":3133948,"url":"https://alion.io/job/abbott-assistant-manager-regulatory-affairs-2","title":"Assistant Manager– Regulatory Affairs","company":{"id":2710,"name":"Abbott","domain":"abbott.com","url":"https://alion.io/company/abbott","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":388,"ghost_share":0.003,"stale_share":0.652,"repost_share":0.026,"time_to_fill_p50_days":14,"computed_at":"2026-10-26T05:57:25Z"}},"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":["Mumbai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":18000,"max_usd":37000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-12T00:00:00Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-24T13:17:30Z","board_verified":false,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"JOB DESCRIPTION:\nCore Job Responsibilities:\nWith Manager Oversight and Supervision:\nGlobal Labeling Portfolio: \nDevelops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process. Ensures CCDS information is based on Subject Matter Expert (SME) contribution.\nOrganizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through.\nWorking with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project.\nWith oversight, independently completes labeling activities assigned. Assesses and approves change requests for labeling documents. Able to participate and contribute to labeling decisions within cross-functional teams.\nSupervises labeling compliance of local labeling documents and reconciles deviations with company labeling documents (e.g. CCDS, corresponding patient information).\nReviews and evaluates new labeling guidelines/policy (High surveillance countries) and determines implications for company labeling documents/labeling of therapeutic area products.\nWorking with Product Leads and SMEs, develops strategic labeling responses, within cross-functional team at appropriate time.\nGRDS Lead/Acting GRDS Lead:\nSupport GRDS Leads/Be a GRDS Lead to support assigned products for all non - cmc documents required by affiliates for regulatory submissions in timely manner.\nFile maintenance:\nMaintains accurate files of labeling change history and associated documents, using the available company electronic systems.\nPromotional Material Release:\nReviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and\nEnsures that promotional materials are accurate and compliant to internal codes of conduct, established regulations.\nAffiliate Support:\nProvide labeling support to affiliates including supporting renewals, geo expansions or any license maintenance activity.\nEducate/guide stakeholders as and when required on labeling procedure with manager’s oversight.\nProduct Maintenance Activities (list is for reference and not limited):\na. Work with RA Ops to prepare Module 2, Module 4 and 5 & have it ready for affiliate to publish.\nb. Coordination of RA information to be included in periodic reports - RMP, PSURs, ACOs (for renewals).\nc. Support renewals with clinical and pre-clinical documentation (EU and EM)\nd. Provide relevant documents for variations to EU & EM affiliates\nTravel:\nUp to 15% may be required\nJOB SPECIFICATIONS:\nSkill, Education, Experience\nMinimum Education:\nBachelor’s degree in Pharmacy or life science related subject with appropriate qualification. \nDiploma in Regulatory Affairs preferred\nMinimum Experience / Training Required:\nIdeally, 5- 7 years work experience, in the pharmaceutical industry\nPrevious experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s)\nExcellent command over spoken and written English is mandatory\nStrong interpersonal skills to work with global teams is critical\nAttentive to detail\nAdvanced word processing knowledge and experience with Microsoft Office products (Word, Excel and Power Point)\nPreferred Qualifications:\nKnowledge and hands-on experience with labeling texts for both health professionals and patients.\nKEY COMPETENCIES REQUIREMENTS:\nManagerial:\nN/A\nBehavioral:\nAdaptability\nEffectively prioritizes short-term (hours/days) work tasks. Responds to learning opportunities. Responds positively to changing situations. Works with others to develop potential alternatives when confronted with problems.\nInitiative\nDemonstrates a willingness to learn new aspects of the business (e.g. International regulations; Clinical & CMC; Generics regulations). Proactively seeks feedback from manager and team members and adapts behavior to improve performance. Maintains strong customer focus.\nInnovation\nIdentifies / tries different or unique ways (within own project / group) to address work problems or opportunities, and/or reduce costs.\nIntegrity\nDelivers high quality results. Meets agreed deadlines. Exhibits honesty and presents complete impartial information. Displays consistency between words and actions. Acknowledges and responds constructively to failures and mistakes. Expresses dissatisfaction constructively, without over-reacting.\nTeamwork\nActively participates within team on shared goals\nThe base pay for this position is\nN/AIn specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nRegulatory OperationsDIVISION:\nEPD Established PharmaLOCATION:\nIndia > Mumbai : BKC BuildingADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nNot specifiedMEDICAL SURVEILLANCE:\nNot ApplicableSIGNIFICANT WORK ACTIVITIES:\nContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)","description_format":"text","description_chars":5083,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiovascular Devices","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-10-23T04:57:00Z"}],"visa":[],"liveness":{"score":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.569,"p_room":0.55,"age_days":14,"expected_fill_days":14,"reasons":["conf:40","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/abbott-assistant-manager-regulatory-affairs-2","json_url":"https://alion.io/job/abbott-assistant-manager-regulatory-affairs-2.json","meta":{"generated_at":"2026-10-26T21:57:47Z","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":29576,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":2710},"rest":"https://alion.io/mcp/rest/get_company?id=2710"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbott-assistant-manager-regulatory-affairs-2"},{"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%2Fabbott-assistant-manager-regulatory-affairs-2"},{"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%2Fabbott-assistant-manager-regulatory-affairs-2"},{"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/abbott-assistant-manager-regulatory-affairs-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbott-assistant-manager-regulatory-affairs-2"}]}