{"id":3641734,"url":"https://alion.io/job/ipsen-senior-manager-cmc-regulatory-strategy","title":"Senior 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":87,"open_postings":26,"ghost_share":0,"stale_share":0.538,"repost_share":0,"time_to_fill_p50_days":50,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","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":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-11-02T21:57:36Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T20:56:02Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Title:\nSenior Manager, 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\nResponsibility for CMC regulatory strategy 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.\nTo manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen’s GRA LT, manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO) SMEs and LT, Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy.\nProvide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers And support the development of junior CMC-reg colleagues.\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 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.\nWork closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.\nDefine and execute the CMC regulatory strategy roadmaps for all products in scope (R&D and LCM) ensuring that regulatory requirements are met. Work closely with CMC regulatory senior management to ensure coherence of strategies across projects.\nEnsure regional regulatory specificities and needs are incorporated into the global plans incl. emerging regulations.\nParticipate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks. Anticipate 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.\nPropose innovative CMC regulatory pathways to accelerate product delivery for patient, as required.\nCommunicate with global regulatory lead to propose de-risking through early communications with worldwide health authorities.\nLead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.\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 pediatric (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.\nContribute to the development and maintenance of efficient, compliant and robust systems, procedures and processes.\nManage all Regulatory interactions for Site Registrations, Site Licences, Site master files, annual reports 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/ Technical Operations and Subject Matter Experts (SME) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format “Ready For Submission” for Ipsen products portfolio in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.\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.\nResponsible for the CMC dossier generation process across all functions: ensure the role of each function involved in the generation of the CMC dossier is clear and will provide accurate data with the correct level of detail in compliance with regulatory requirement.\nManage timely and efficiently the Response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical Development/ technical Operations teams and Subject Matter Experts (SMEs) as necessary to reach submission approval.\nPrepare and maintain the necessary CMC trackers, monitor progress using KPIs and provide regular updates to the team.\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.\nParticipate in the monitoring of the external environment to identify trends and assess potential impact on business and communicate this information to stakeholders.\nActively participate in Industry associations or working groups and ensure company’s interests are taken into account.\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\nEstablish and maintain an excellent working relationship with Pharm Dev/ TechOps teams and the Ipsen regulatory community, in particular with Ipsen Global Regulatory Affairs Therapeutic Area Leads, European and intercontinental leads, Regulatory Operations Publishers and Ipsen affiliates/partners to ensure efficient coordination of regulatory submissions.\nLead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.\nBuild effective relationships with global/regional regulators through agencies meetings, scientific advice and scientific workshops to ease validation on Ipsen strategy.\nEnsure the CMC-Regulatory Strategy Director/Senior Director, is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).\nActively contribute to the Regulatory Community life.\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 direct experience in CMC regulatory environment in pharmaceutical industry (“approximately 8 - 10 years’ experience)”.\nProven experience in managing CMC-regulatory activity for products in a worldwide environment.\nProven experience in CMC regulatory on R&D and LCM portfolio.\nExperience of Health Authorities interaction.Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.\nProven ability to learn respect in a cross-functional global environment.\nProven understanding of CMC regulatory processes and requirement in US, EU, and export countries particularly JP, China, Brazil, Russia….\nExcellent written, verbal and interpersonal communication skills, highly organized\nAbility to handle multiple priorities and complex projects in a fast-paced environment.\nStrong analytical and problem-solving skills.\nKnowledge & Experience (preferred):\nSmall molecule and biological experience\nExperience with regulatory management of CMC activities for medical devices and maintenance of associated technical files including interactions with a Notified Body.\nEducation / Certifications (essential):\nAdvanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)\nEducation / Certifications (preferred):\nNA\nLanguage(s) (essential):\nEnglish: fluent\nLanguage(s) (preferred):\nFrench fluent\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":11250,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"French","level":"Advanced (C1)","optional":false},{"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":1,"expected_fill_days":50,"reasons":["conf:4","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/ipsen-senior-manager-cmc-regulatory-strategy","json_url":"https://alion.io/job/ipsen-senior-manager-cmc-regulatory-strategy.json","meta":{"generated_at":"2026-11-05T02:35:21Z","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":3276,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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-senior-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-senior-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-senior-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-senior-manager-cmc-regulatory-strategy\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fipsen-senior-manager-cmc-regulatory-strategy"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3641734}},{"tool":"search_jobs","arguments":{"company":"ipsen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3641734},"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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