{"id":3641735,"url":"https://alion.io/job/ipsen-manager-cmc-regulatory-strategy","title":"Manager CMC Regulatory Strategy","company":{"id":5773,"name":"Ipsen","domain":"ipsen.com","url":"https://alion.io/company/ipsen","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":85,"open_postings":25,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":50,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Paris, France","London, United Kingdom"],"countries":["FR","GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-11-02T21:57:36Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-03T14:05:46Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Title:\nManager CMC Regulatory StrategyCompany:\nIpsen Innovation (SAS)About Ipsen:\nIpsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.\nOur passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!\nFor more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.\nJob Description:\nWHAT - Summary & Purpose of the Position\nPrepare the CMC regulatory strategy activities for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management as assigned by CMC regulatory senior management including leading the preparation of the CMC submission dossiers.\nTo manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen’s manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO), Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy.\nWHAT - Main Responsibilities & Technical Competencies\nCMC Regulatory Strategy:\nLead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects (new products in development and/ or commercial product(s) for both lifecycle management and geographical expansion through new MAA registrations) ensuring the CMC reg risks are identified, assessed, shared and managed as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met. Work efficiently with CMC regulatory senior management to ensure coherence of strategies across projects.\nLead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams, to generate effective CMC regulatory dossiers as per the project timelines.\nWrite regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures and quality events as appropriate.\nWork closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of the assigned projects and products.\nAnticipate any gaps for planned regulatory submissions, taking into account emerging regulations and country specific requirements, prioritising and planning associated regulatory strategies to address any identified gaps.\nCommunicate with global regulatory lead to propose to de-risking some CMC strategic decisions through early communications and validation with worldwide health authorities.\nLead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.\nProvide CMC regulatory expertise to project teams.\nPropose innovative CMC regulatory pathways to accelerate product delivery for patient enrolment in clinical studies, as required.\nReview of the Target Product Profile (TPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS/ / Investigational brochures to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including paediatric (presentation, formulation, excipients) and ROW considerations, as required.\nAssess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice and clearly communicating any Regulatory impact and CMC-Regulatory supporting data requirements for subsequent variations/ amendments.\nManage all Regulatory interactions for Site Registrations, Site Licences, Site master files s and site accreditations with Regulatory Authorities, Alliance partners and CMO’s for assigned product(s) as applicable.\nCMC Dossier preparation:\nEnsure collaboration with teams in Pharmaceutical Development and in Technical Operations, as well as with Subject Matter Experts (SMEs) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD), variations, responses to question and MAA modules 1, 2 & 3 in the correct “Ready For Submission” format for assigned products, in compliance with eCTD requirement.\nWork effectively with Global Regulatory Affairs (GRA) Therapeutic area, and GRA Regulatory Operations teams to ensure that CMC-Regulatory submissions comply with Ipsen group policies and procedures. Ensure that submissions are planned and scheduled appropriately to align with Technical Operations implementation requirements or clinical supply needs, while ensuring adequate time for review, approval and publishing tasks. Ensure the consistency of CMC data across the different modules of the dossier.\nManage submission of annual reports for assigned product(s) as applicable.\nCMC Regulatory expertise & Regulatory intelligence\nParticipate and represent CMC regulatory strategy department in CMC project teams and Global project team, as necessary, for the assigned projects.\nProactively provide Ipsen functions (e.g. Pharm Dev, TechOps, SMEs, GRA, Global project teams, etc) with CMC regulatory expertise.\nCommunicate key regulatory CMC related guidance’s to Pharmaceutical Development/ technical Operations teams, SMEs and other stakeholders within Ipsen.\nPerform CMC-Regulatory Intelligence activities as required and work with cross-functional departments to ensure related operations are compliant.\nResources and performance\nCoach and develop junior resource within the regulatory strategic CMC Group.\nLead and manage assigned projects and associated communication and reporting.\nMonitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.\nCommunication\nEnsure the CMC-Regulatory Strategy Director/Senior Director, is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).\nAssess CMC Regulatory activities and process performance, identify areas for improvement. Propose and lead continuous improvement process initiatives within the CMC-Regulatory Strategy function.\nCMC-Reg Strategy lead contact with sites, external Alliance partners and CMOs ensuring aligned strategy and optimised communication as applicable.\nCoach and develop junior resource within the CMC regulatory strategy team.\nHOW - Behavioural Competencies Required\nPuts values and ethics at the forefront of everything.\nAnchors Ipsen's purpose, mission and commitments to patients and society.\nIdentifies contradictory information/demands/inputs to effectively solve problems.\nDevelops and evaluates alternative scenario and solutions.\nAble to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.\nMethodically assesses, transparently shares, and makes risk-informed decisions.\nEstablishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society.\nDisplays a commitment to sharing and implementing best practices and committed to excellence in execution.\nHOW - Knowledge & Experience\nKnowledge & Experience (essential):\nProven CMC Regulatory experience in managing small molecules and/ or biologicals in a worldwide environment “(approximately 3-6 years’ experience)”.\nExperience should include registration and clinical development (IND/IMPD) and/ or post-approval activities in US and EU and major RoW markets.\nDemonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.\nStrong project planning skills and ability to develop sound CMC-Regulatory strategy for multiple global changes.\nProven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.\nSound technical knowledge of the manufacture of pharmaceuticals and appropriate understanding of all regulatory CMC disciplines.\nStrong knowledge of current global regulatory requirements pertaining to the manufacture of pharmaceutical drug substances and drug products.\nUnderstanding of Pharmaceutical Quality activities and assessment of cGMP compliance, site registration and licensing.\nProven experience in both internal and external Stakeholder management.\nProven experience in handling multiple priorities and complex projects in a fast-paced environment.\nAnalytical mindset and excellent attention to detail.\nExcellent critical thinking, written, verbal and interpersonal communication skills.\nKnowledge & Experience (preferred):\nExperience with regulatory management of CMC activities for medical devices and maintenance of associated technical files including interactions with a Notified Body.\nExperience of Health Authorities interaction.\nExperience should include activities in export countries particularly e.g. China, Japan, Brazil.\nEducation / Certifications (essential):\nAdvanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science).\nLanguage(s) (essential):\nFluent in English\nLanguage(s) (preferred):\nFluent\n#LI-MM1 #LI-hybrid\nNous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même","description_format":"text","description_chars":10693,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"France","iso":"FR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biologics & Biosimilars","Oncology Therapeutics","Neurology & CNS Therapeutics","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-02T21:57:36Z"}],"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":50,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/ipsen-manager-cmc-regulatory-strategy","json_url":"https://alion.io/job/ipsen-manager-cmc-regulatory-strategy.json","meta":{"generated_at":"2026-11-03T19:20:28Z","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":1462,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":5773},"rest":"https://alion.io/mcp/rest/get_company?id=5773"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fipsen-manager-cmc-regulatory-strategy"},{"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%2Fipsen-manager-cmc-regulatory-strategy"},{"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%2Fipsen-manager-cmc-regulatory-strategy"},{"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/ipsen-manager-cmc-regulatory-strategy\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fipsen-manager-cmc-regulatory-strategy"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3641735}},{"tool":"search_jobs","arguments":{"company":"ipsen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3641735},"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. Docs: https://alion.io/developers"}}