{"id":3282713,"url":"https://alion.io/job/proclinical-regulatory-specialists","title":"Regulatory Specialists","company":{"id":2116512,"name":"Proclinical","domain":"proclinical.com","url":"https://alion.io/company/proclinical","size_band":"201-500","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Basel, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":97000,"max_usd":252000,"period":"year","method":null,"sample_n":1456},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-26T09:01:33Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-27T09:32:17Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Ready to shape the global regulatory strategy behind life-changing medicines and ensure products reach patients worldwide?\nProclinical is seeking three experienced Regulatory Specialists to join a dynamic team in Switzerland, on a contract basis. This role focuses on technical regulatory affairs, particularly Chemistry, Manufacturing, and Controls (CMC), with opportunities to work across the product lifecycle. You will play a key role in managing global submissions, ensuring compliance, and collaborating with cross-functional teams to support clinical and commercial products.\nPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport.\nResponsibilities:\nManage and execute global technical regulatory submissions for clinical and commercial products, ensuring compliance with local and regional requirements.\nOversee the regulatory lifecycle management of assigned products, including evaluating change records and maintaining CMC documentation in Veeva systems.\nRepresent Pharma Technical Regulatory (PTR) on cross-functional project teams, providing regulatory advice and assessing impacts.\nPartner with technical teams to ensure continuous compliance and develop strategies for early approvals of Clinical Trial Applications (CTAs) and lifecycle extensions.\nCommunicate directly with regulatory authorities and external partners on technical matters.\nIdentify regulatory risks, optimize tracking systems, and lead workflow simplification efforts to enhance operational efficiency.\nMonitor global regulatory guidelines and assess their impact on product portfolios and strategies.\nKey Skills and Requirements:\nBachelor's degree in a relevant field.\nExperience in CMC regulatory or technical regulatory affairs.\nProficiency in Veeva Document Management systems for regulatory submissions.\nFluent in English (C1 level).\nStrong problem-solving skills and ability to streamline processes.\nAdditional Role-Specific Requirements:\nPosition 1: Regulatory Specialist - Clinical (Early-Stage Development, CMC Focus)\nExperience supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).\nHands-on experience with early clinical trial submissions and CTAs.\nPosition 2: Regulatory Specialist - Commercial (Post-Marketing, Remediation)\nExpertise in post-approval regulatory maintenance, change controls, and managing regulatory deviations.\nFamiliarity with legacy product clean-up and integration into regulatory systems.\nProficiency in Veeva RIM environments.\nNice to Haves:\nGerman language skills.\nPrior experience in biologics.\nIf you are having difficulty in applying or if you have any questions, please contact Olivier Worch at .\nApply Now:\nIf you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.\nProclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.\nBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy","description_format":"text","description_chars":3376,"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":[{"language":"German","level":"All levels","optional":true},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-26T17:16:38Z"}],"visa":[],"liveness":{"score":54,"band":"ok","label":"Likely open","p_open":1,"p_active":0.542,"p_room":1,"age_days":0,"expected_fill_days":45,"reasons":["conf:1","agency","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/proclinical-regulatory-specialists","json_url":"https://alion.io/job/proclinical-regulatory-specialists.json","meta":{"generated_at":"2026-10-27T12:53:02Z","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":805,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":2116512},"rest":"https://alion.io/mcp/rest/get_company?id=2116512"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fproclinical-regulatory-specialists"},{"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%2Fproclinical-regulatory-specialists"},{"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%2Fproclinical-regulatory-specialists"},{"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/proclinical-regulatory-specialists\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fproclinical-regulatory-specialists"}]}