{"id":3050901,"url":"https://alion.io/job/icon-early-developement-global-regulatory-lead","title":"Early Developement Global Regulatory Lead","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":49,"ghost_share":0,"stale_share":0.98,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mechelen, Belgium"],"countries":["BE"],"hiring_countries":["BE"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":62000,"max_usd":147000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":137},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-29T17:35:48Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"Global Regulatory LeadAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nThe Global Regulatory Lead, Early Development (ED-GRL) is a senior leader within ICON's Early Development Regulatory Team (EDRT), providing strategic regulatory leadership across the development lifecycle of innovative therapeutics. This role serves as a key business partner to development teams, guiding global regulatory strategy from preclinical and pre-nomination activities through First-in-Human (FIH) studies and early clinical development.\nWorking collaboratively with cross-functional stakeholders, the ED-GRL will drive patient-focused regulatory strategies, support accelerated development pathways, lead agency interactions, and ensure programs are positioned for successful transition into later-stage development.\nWhat You Will Be Doing\nProvide strategic global regulatory leadership for assigned early development programs, ensuring clear regulatory direction, proactive risk management, and alignment across multidisciplinary teams.\nDevelop and execute innovative global regulatory strategies that support expedited clinical development and critical early development milestones through completion of First-in-Human studies.\nEmbed patient-focused approaches into regulatory planning and development strategies.\nServe as a key member of the Early Development Regulatory Team, contributing to team growth, culture, and operational excellence.\nRepresent Regulatory Affairs within governance committees and development forums, providing timely and actionable regulatory guidance to support business decision-making.\nPartner closely with asset teams to facilitate seamless transition of programs from early to later stages of development.\nCollaborate with regulatory leadership to establish and enhance processes, infrastructure, and operational efficiencies.\nMentor, coach, and develop members of the regulatory organization.\nBuild and maintain strong relationships with internal stakeholders across Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development.\nMonitor, assess, and communicate evolving global regulatory requirements and policy developments that may impact development programs.\nLead interactions with health authorities and oversee external regulatory vendors to ensure high-quality deliverables and regulatory engagement.\nProvide hands-on support for key regulatory submissions and interactions, including Scientific Advice procedures, INDs, CTAs, expedited development pathways, and other regulatory activities.\nContribute regulatory expertise to business development assessments, due diligence activities, and portfolio strategy discussions, as appropriate.\nWhat You Need\nRequired Qualifications\nBachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline.\nAt least 5-7 years of experience leading global regulatory strategies and teams.\nDeep knowledge of global regulatory frameworks, including significant experience with major regulatory agencies such as FDA, EMA, and PMDA.\nDemonstrated experience supporting innovative therapies through early clinical development, including First-in-Human studies.\nProven expertise in developing and implementing global regulatory strategies that support efficient asset progression and key development decisions.\nExperience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways.\nStrong leadership skills with the ability to influence without authority in a highly matrixed organization.\nExcellent verbal, written, presentation, and stakeholder management skills.\nStrong project management, prioritization, and organizational capabilities.\nPreferred Qualifications\nAdvanced scientific degree (PhD, PharmD, MD, or equivalent).\nExperience across both early and late-stage drug development.\nScientific expertise in Immunology and/or related therapeutic areas.\nKnowledge of diverse therapeutic modalities, including biologics, monoclonal antibodies, peptides, siRNA, and small molecules.\nExperience integrating biomarker strategies, patient engagement initiatives, and patient-relevant evidence into development and regulatory plans.\nExperience supporting business development transactions, portfolio assessments, and regulatory due diligence.\nDemonstrated interest in leveraging AI-enabled and digital solutions to enhance regulatory strategy, intelligence gathering, and document development.\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? Please click here to apply","description_format":"text","description_chars":5918,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Retirement plans"],"hiring_locations":[{"name":"Belgium","iso":"BE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-22T02:26:09Z"}],"visa":[],"liveness":{"score":42,"band":"fade","label":"Fading","p_open":1,"p_active":0.56,"p_room":0.75,"age_days":9,"expected_fill_days":12,"reasons":["conf:4","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/icon-early-developement-global-regulatory-lead","json_url":"https://alion.io/job/icon-early-developement-global-regulatory-lead.json","meta":{"generated_at":"2026-10-30T00:32:06Z","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":594,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":5677},"rest":"https://alion.io/mcp/rest/get_company?id=5677"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ficon-early-developement-global-regulatory-lead"},{"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%2Ficon-early-developement-global-regulatory-lead"},{"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%2Ficon-early-developement-global-regulatory-lead"},{"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/icon-early-developement-global-regulatory-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ficon-early-developement-global-regulatory-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3050901}},{"tool":"search_jobs","arguments":{"company":"iconplc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3050901},"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"}}