{"id":3267828,"url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-2","title":"Regulatory Affairs Manager","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","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":92,"open_postings":129,"ghost_share":0,"stale_share":0.496,"repost_share":0.07,"time_to_fill_p50_days":19,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","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":66000,"max_usd":159000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":136},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-10-26T10:18:46Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-29T02:51:41Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Type: Permanent\nLocation: Pancras Square\nIntroduction to the role\nDeliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through the provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through valued contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.\nAccountabilities\nGenerate Competitive Licences (0-40%)\nRegulatory Compliance & Governance (0-10%)\nCommercial Support (0-15%)\nFormulate and Influence Regulatory Strategy (0-15%)\nLead the Organisation and Improve Productivity (0-10%)\nClinical Support (0-10%)\nEssential Skills/Experience\nLife sciences degree or appropriate professional qualifications.\n4+ years’ experience working within a regulatory affairs organisation in a UK-based or global pharmaceutical company.\nPost-Brexit UK regulatory experience.\nBusiness relationship management skills and the ability to navigate and coordinate cross-functional interactions..\nOperational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role\nDemonstrable negotiation skills.\nAbility to make optimal use of IT systems.\nKnowledge of the external regulatory environment and regulatory science expertise support building a productive, positive and trustworthy relationship with the UK MHRA to drive meaningful interactions to the benefit of patients.\nLifecycle maintenance of UK Regulatory licenses, including different types of submissions, including but not limited to CMC, Labelling, etc.\nOptimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines.\nDevelopment of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies.\nApplication of knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities.\nApplication of drug development knowledge.\nAudit and inspection knowledge.\nDesirable Skills/Experience\nExperience with clinical trial applications and trial maintenance activities, including the use of in-vitro diagnostics (IVDs) in the clinical trial setting.\nExperience using AI solutions to simplify and improve departmental processes/ways of working.\nExperience in creating and delivering regulatory strategies for marketing authorisation applications and new indications.\nExperience working in Veeva systems.\nManagement of reactions to change while remaining effective in new work situations and times of uncertainty; assessment, planning and management of the impact of changes on stakeholders; and application of change management techniques to engage stakeholders appropriately.\nA robust understanding of a relevant disease and therapeutic area, including the regulatory and health technology assessment environment in the major markets, the competitor landscape, and predictable barriers/obstacles in development.\nAt AstraZeneca, we change the practice of medicine by generating compelling medical evidence that helps physicians better treat patients at every point in their journey. Our cross-functional teams work seamlessly together, leveraging diverse skills to advance our pipeline and redefine cancer treatment. We foster a culture of openness, transparency, ambition, and drive. Here, you will find a supportive environment where you can grow your career while making a significant impact on patients' lives.\nReady to make a difference? Apply now!\nDate Posted\n26-Oct-2026Closing Date\n09-Nov-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.","description_format":"text","description_chars":4590,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-26T10:18:46Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Graduate Trainee, Senior or Specialist Worker, Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Global Business Mobility: Graduate Trainee; Global Business Mobility: Senior or Specialist Worker; Skilled Worker","cap_exempt":false,"checked_at":"2026-10-28T06:26:45+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":19,"reasons":["conf:5","velocity","win:early","comp:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-2","json_url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-2.json","meta":{"generated_at":"2026-10-29T03:12:40Z","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":4837,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":13195},"rest":"https://alion.io/mcp/rest/get_company?id=13195"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fastrazeneca-regulatory-affairs-manager-2"},{"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%2Fastrazeneca-regulatory-affairs-manager-2"},{"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%2Fastrazeneca-regulatory-affairs-manager-2"},{"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/astrazeneca-regulatory-affairs-manager-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastrazeneca-regulatory-affairs-manager-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3267828}},{"tool":"search_jobs","arguments":{"company":"astrazeneca.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3267828},"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. 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