{"id":1661239,"url":"https://alion.io/job/proclinical-associate-director-regulatory-affairs","title":"Associate Director - Regulatory Affairs","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":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["London, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":114000,"max_usd":238000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":388},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-25T09:06:20Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-24T17:07:58Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"Ready to lead global regulatory strategy and influence the development of innovative oncology therapies on a worldwide scale?\nProclinical is seeking an Associate Director of Regulatory Affairs to join a dynamic team in the oncology and pharmaceutical sector. In this role, you will play a key part in leading global regulatory strategies and submissions for development programs. This is a remote, contract-based position requiring expertise in regulatory affairs and a strong ability to navigate cross-functional collaboration.\nResponsibilities:\nRegulatory and Program Oversight\nServe as Global Regulatory Lead for development programs across the portfolio.\nDevelop, maintain, and execute program level regulatory strategies aligned with corporate objectives and stage of development.\nIdentify regulatory risks and develop mitigation strategies aligned with clinical, nonclinical, and CMC development plans.\n Regulatory Submission Planning and Health Authority Engagement\nLead crossfunctional planning of regulatory submissions and amendments including ongoing lifecycle management activities (annual reports etc).\nEnsure regulatory alignment across clinical, nonclinical, and CMC components of submissions and ensure alignment between internal teams to support submission timelines.\nLead strategic planning and preparation for regulatory interactions, develop regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.\nManage submission, agency correspondence, and follow up related to regulatory designations. Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests\nAuthor and lead preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.\nKey Skills and Requirements:\nBachelor's degree in life sciences or related discipline required; advanced degree preferred.\nMinimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.\nExperience in Radiopharmaceuticals would be beneficial\nDemonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for early/late clinical development programs.\nExperience with EMA and CTIS preferred\nExperience with radiopharmaceuticals preferred\nStrong scientific/medical writing skills, with the ability to condense scientific information and data into regulatory narratives.\nAbility to operate effectively and independently in a fast-paced, clinical development environment.\nIf you are having difficulty in applying or if you have any questions, please contact Peter Duvall 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":3419,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-02T03:48:38Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker","cap_exempt":false,"checked_at":"2026-10-24T06:24:00+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":48,"band":"ok","label":"Likely open","p_open":1,"p_active":0.539,"p_room":0.9,"age_days":28,"expected_fill_days":45,"reasons":["conf:3","agency","velocity","win:mid","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/proclinical-associate-director-regulatory-affairs","json_url":"https://alion.io/job/proclinical-associate-director-regulatory-affairs.json","meta":{"generated_at":"2026-10-25T04:01:06Z","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":5227,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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-associate-director-regulatory-affairs"},{"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-associate-director-regulatory-affairs"},{"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-associate-director-regulatory-affairs"},{"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-associate-director-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fproclinical-associate-director-regulatory-affairs"}]}