{"id":1820698,"url":"https://alion.io/job/cpl-regulatory-affairs-director","title":"Regulatory Affairs Director","company":{"id":2268173,"name":"Cpl","domain":"cpl.com","url":"https://alion.io/company/cpl-com","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":27,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":19,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_regions","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":["DE","FR","GB","AT","BE","BG","HR","CY","CZ","DK","FI","HU","IE","IT","NL","PL","RO","ES","SE","EE","GR","LV","LT","LU","MT","PT","SK","SI"],"hiring_countries_total":28,"salary":{"min":130000,"max":150000,"currency":"EUR","period":"year","gross":null,"usd_annual":168869},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-17T10:37:06Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-10-21T03:58:37Z","board_verified":true,"closed_at":null,"days_open":33,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":33},"description":"JO-2609-568854\nRegulatory Affairs Director (UK, Ireland, or EU - Remote)\nEmployment Type: Full-Time, Permanent\nReports To: VP, Global Head of Regulatory Affairs\nOur client is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic products for rare dermatological diseases. They are seeking a strategic Director of Regulatory Affairs to lead the European regulatory strategy, oversee submission execution, and ensure compliance across all development programs.\nYou will serve as primary regulatory contact with the MHRA, EMA, and other competent authorities, while simultaneously handling hands-on operational tasks.\nWhat You’ll Do\nUK & EU Regulatory Strategy\nDrive Regional Strategy: Develop and execute UK and EU regulatory strategies across CMC, clinical, and nonclinical areas for our rare disease pipeline.\n Lead Submissions: Oversee regional filings including Clinical Trial Applications (CTAs) under EU CTR, IMP dossiers, variations, PIPs, and future MAA submissions.\n Health Authority Relations: Serve as the primary liaison for the EMA and MHRA. Lead preparations for Scientific Advice meetings and manage responses to Requests for Information (RFIs).\nRegulatory Intelligence: Act as the internal expert on evolving UK and EU guidelines, including post-Brexit divergences, and advise teams on regional impact.\nHands-on Regulatory Writing & Operations\n Author & Review: Personally contribute to the writing, formatting, and quality control (QC) of global regulatory documents.\nSystem Operations: Manage EU CTR submissions via CTIS and UK submissions via IRAS.\n Document Management: Draft and maintain clinical trial notifications, amendments, CMC modules (Module 2.3/Module 3), labeling, RMPs, PIPs, and Investigator’s Brochures.\nData Integrity: Ensure all submission content is accurate, cross-checked against source data, and compliant with regional and ICH guidelines.\nWhat You’ll Bring\nIndustry Experience: Extensive progressive experience in Regulatory Affairs within the biopharmaceutical or biotech industry.\n Regulatory Track Record: Proven, hands-on experience navigating EU CTR (via CTIS) and UK MHRA pathways (via IRAS). Experience with Scientific Advice meetings and MAA preparation is highly valued.\nTherapeutic Expertise: Background in rare diseases or dermatology is a strong advantage.\nMindset: A strong balance of high-level strategic thinking and a willingness to handle day-to-day writing and operational tasks in a lean environment.\n Education: Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.); an advanced degree (MSc, PhD, PharmD) is preferred.\nWhat We Offer\nThe opportunity to shape the regulatory pathway for much-needed rare disease therapies.\nA collaborative, fast-paced, and entrepreneurial company culture.\nFlexible remote working arrangements within the UK, Ireland, or EU.\nIf interested - please send your updated CV : \nPlease note : Candidates must have full, unrestricted working rights in Ireland (Stamp 4 or EU passport)\n#LI-DM1","description_format":"text","description_chars":3058,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Germany","iso":"DE","kind":"region"},{"name":"France","iso":"FR","kind":"region"},{"name":"United Kingdom","iso":"GB","kind":"country"},{"name":"Austria","iso":"AT","kind":"region"},{"name":"Belgium","iso":"BE","kind":"region"},{"name":"Bulgaria","iso":"BG","kind":"region"},{"name":"Croatia","iso":"HR","kind":"region"},{"name":"Cyprus","iso":"CY","kind":"region"},{"name":"Czech Republic","iso":"CZ","kind":"region"},{"name":"Denmark","iso":"DK","kind":"region"},{"name":"Finland","iso":"FI","kind":"region"},{"name":"Hungary","iso":"HU","kind":"region"},{"name":"Ireland","iso":"IE","kind":"country"},{"name":"Italy","iso":"IT","kind":"region"},{"name":"Netherlands","iso":"NL","kind":"region"},{"name":"Poland","iso":"PL","kind":"region"},{"name":"Romania","iso":"RO","kind":"region"},{"name":"Spain","iso":"ES","kind":"region"},{"name":"Sweden","iso":"SE","kind":"region"},{"name":"Estonia","iso":"EE","kind":"region"},{"name":"Greece","iso":"GR","kind":"region"},{"name":"Latvia","iso":"LV","kind":"region"},{"name":"Lithuania","iso":"LT","kind":"region"},{"name":"Luxembourg","iso":"LU","kind":"region"},{"name":"Malta","iso":"MT","kind":"region"},{"name":"Portugal","iso":"PT","kind":"region"},{"name":"Slovakia","iso":"SK","kind":"region"},{"name":"Slovenia","iso":"SI","kind":"region"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-04T05:25:23Z"}],"visa":[],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.314,"p_room":0.45,"age_days":33,"expected_fill_days":19,"reasons":["conf:1","agency","stale_co","urgency","velocity","win:tail","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":168869,"is_top_pay":false},"html_url":"https://alion.io/job/cpl-regulatory-affairs-director","json_url":"https://alion.io/job/cpl-regulatory-affairs-director.json","meta":{"generated_at":"2026-10-21T07:53:52Z","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":11239,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":2268173},"rest":"https://alion.io/mcp/rest/get_company?id=2268173"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcpl-regulatory-affairs-director"},{"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%2Fcpl-regulatory-affairs-director"},{"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%2Fcpl-regulatory-affairs-director"},{"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/cpl-regulatory-affairs-director\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcpl-regulatory-affairs-director"}]}