{"id":3798178,"url":"https://alion.io/job/pfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support","title":"Associate Manager I - Reg CMC Strategy, NP CMC Support","company":{"id":3480,"name":"Pfizer","domain":"pfizer.com","url":"https://alion.io/company/pfizer","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":27,"ghost_share":0,"stale_share":0.63,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Management","role_family":"Management","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":["Mumbai, India","Chennai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-05T10:21:19Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-06T08:48:12Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Provides functional support to the Regulatory CMC Strategist for the Annual Reports & License Renewals, Innovative Products Team, working closely with the CMC Global Regulatory Strategist - CMC (GRS-CMC) and cross-functional teams (RIO EH/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.\nIndividual Contributor - responsible for own work (requiring periodic review) under general supervision:\nRenewals CMC Responsibilities:\nDemonstrates Strong Knowledge and Understanding of Process Principles and Concepts; Activities Include, but Are Not Limited to:\nManages day-to-day work activities associated with assigned renewal applications within agreed-upon timelines; utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.\nDevelops renewal regulatory strategies while considering registered content, in collaboration with GRS-CMC and Group Lead.\nPrepares CMC contributions for renewal applications for assigned products across global markets; authors and/or compiles renewal documentation (e.g., Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A) under the guidance of GRS-CMC and/or Group Lead and within agreed timelines.\nCoordinates Module 1 and Module 3.2.R ancillary documents, as needed.\nReviews technical and supporting information for submission to support renewal applications.\nDevelops technical justifications for changes for agency submissions, as required.\nSupports / Author query responses and/or commitment management in collaboration with GRS-CMC.\nLiaises with Pfizer Global Supply and other support functions, as needed.\nReviews and applies relevant regulatory guidelines for authoring renewal documentation.\nMakes decisions to resolve minor to moderate issues in standard situations in accordance with guidance and policies; escalates complex issues and identified risks to GRS-CMC, Group Lead, and/or appropriate leadership.\nCoordinates internal document review and sign-off activities.\nUtilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA) to build expertise and may begin guiding or mentoring colleagues within the Renewals and/or cross-brand teams.\nEnsures compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates.\n\nAnnual Report CMC Responsibilities:\nManages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.\nReviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC.\nAuthors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the GRS-CMC as appropriate and within agreed timelines.\no Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled\no Reviews technical/supportive information for submission to support AR changes\no Manages and reviews stability contributions for accuracy and consistency with commitments\no Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.\no Develops technical justification of change for agency submission as needed\no Updates impacted dossier components as needed\no Coordinates M3.2.R Ancillary documents as needed\no Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership\nCoordinates internal document review and sign off.\nUtilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Veeva) etc., as appropriate.\nEnsures compliance to Pfizer internal procedures and training SOPs (PLA).\nØ Preferred Education:\nMinimum - Postgraduate in Pharmacy / Science Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)\nØ Preferred Experience:\nMinimum 4-6 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization handling new submissions and / or LCM submission to global health authorities especially USFDA, EMA and other EU authorities. Experience in CMC strategy and legislation that pertains to Biologics and Biosimilars is preferable.\nØ Preferred Attributes:\nGood oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team\nØ Technical Skills:\no Regulatory requirements of post approval changes for global market.\no Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals.\no Knowledge in retrieving information from company’s and regulatory agency databases.\nBasiclevelofknowledgeongeneralstandards,processesandpoliciesofPfizer/Pharmaceutical manufacturing Industry.\nWork Location Assignment: Hybrid\nPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.\nTo learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.\nRegulatory Affairs","description_format":"text","description_chars":5580,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-05T10:21:19Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":0,"expected_fill_days":13,"reasons":["conf:2","stale_co","velocity","win:early","comp:junior,brand"],"computed_at":"2026-11-06T05:58:05Z"},"pay":null,"html_url":"https://alion.io/job/pfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support","json_url":"https://alion.io/job/pfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support.json","meta":{"generated_at":"2026-11-06T09:50:47Z","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":17859,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":3480},"rest":"https://alion.io/mcp/rest/get_company?id=3480"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support"},{"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%2Fpfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support"},{"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%2Fpfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support"},{"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/pfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpfizer-associate-manager-i-reg-cmc-strategy-np-cmc-support"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3798178}},{"tool":"search_jobs","arguments":{"company":"pfizer.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3798178},"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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