{"id":2565353,"url":"https://alion.io/job/viatris-manager-regulatory-cmc-sciences-injectables-3","title":"Manager Regulatory CMC Sciences (Injectables)","company":{"id":706446,"name":"Viatris","domain":"viatris.fi","url":"https://alion.io/company/viatris","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":97,"open_postings":320,"ghost_share":0.044,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":54,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Early Careers","role_family":"Early Careers","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-14T21:52:14Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-22T04:56:16Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":7},"description":"Mylan TeorantaViatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.\nWe have been included on number of award lists that demonstrate the impact we are making. \nOur global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.\nFor those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.\nThe Role & What You Will Be Doing\nEvery day, we rise to the challenge to make a difference and here’s how the role will make an impact:\nDevelop and implement global CMC regulatory strategies for injectable products.\n\nInterpret and communicate regulatory requirements and provide risk-based regulatory guidance to stakeholders.\n\nPrepare, review and analyse global CMC submission documentation and lifecycle management activities.\n\nSupport manufacturing sites with regulatory strategies and documentation for variations and supplements.\n\nEnsure regulatory compliance through effective management of CMC activities and change controls.\n\nCollaborate with regional regulatory, labelling, quality, supply chain and manufacturing teams to support submissions and agency interactions.\n\nProvide responses to health authority queries and participate in regulatory authority meetings and inspections as required.\n\nAct as a regulatory subject matter expert within cross-functional project teams.\n\nMentor colleagues and contribute to knowledge sharing and capability development.\n\nMaintain awareness of emerging regulatory requirements and industry trends, communicating impacts to relevant stakeholders.\n\nAbout Your Skills & Experience\nFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:\nBachelor's degree (or equivalent) in a science-related discipline.\n\nExperience working within Regulatory Affairs in the pharmaceutical industry.\n\nHands-on experience authoring post-approval CMC lifecycle management submissions.\n\nHands-on Regulatory CMC experience supporting injectable products.\n\nStrong knowledge of global regulatory requirements, particularly US regulations.\n\nExperience with injectable, parenteral or combination product submissions.\n\nExcellent written and verbal communication skills, including preparation and review of regulatory documentation.\n\nStrong understanding of cGMP requirements, CFR, USP, Ph. Eur. and FDA guidance.\n\nExperience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions.\n\nProficiency with Microsoft Office applications and regulatory systems such as TrackWise and Documentum.\n\nStrong project management skills and the ability to deliver to time, cost and quality standards.\n\nPrevious people management experience would be advantageous.\n\nTOPRA certification or RAC qualification preferred.\n\nAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.\nBenefits at Viatris\nAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:\nExcellent career progression opportunities\n\nWork-life balance initiatives\n\nBonus scheme\n\nHealth insurance\n\nPension\n\nDiversity & Inclusion at Viatris\nAt Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion\nSustainability at Viatris\nCorporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility\nAt Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.\nViatris is an Equal Opportunity Employer.","description_format":"text","description_chars":5469,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Health insurance"],"hiring_locations":[{"name":"Ireland","iso":"IE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Generic Drugs","OTC & Consumer Health Products"],"lifecycle":[{"event":"open","at":"2026-10-14T21:52:14Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":7,"expected_fill_days":54,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/viatris-manager-regulatory-cmc-sciences-injectables-3","json_url":"https://alion.io/job/viatris-manager-regulatory-cmc-sciences-injectables-3.json","meta":{"generated_at":"2026-10-22T09:20:04Z","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":6031,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":706446},"rest":"https://alion.io/mcp/rest/get_company?id=706446"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fviatris-manager-regulatory-cmc-sciences-injectables-3"},{"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%2Fviatris-manager-regulatory-cmc-sciences-injectables-3"},{"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%2Fviatris-manager-regulatory-cmc-sciences-injectables-3"},{"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/viatris-manager-regulatory-cmc-sciences-injectables-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fviatris-manager-regulatory-cmc-sciences-injectables-3"}]}