{"id":2084898,"url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-ii","title":"Regulatory Affairs Manager II","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":124,"ghost_share":0,"stale_share":0.5,"repost_share":0.056,"time_to_fill_p50_days":20,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Public Policy","role_family":"Public Policy","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":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":15500,"max_usd":35000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":90},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-08T11:44:23Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-27T03:33:53Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"JOB TITLE: REGULATORY AFFAIRS MANAGER II\nCAREER LEVEL: D\nRole Type: Individual Contributor for Global Markets\nABOUT ASTRAZENECA\nAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.\nABOUT THE ROLE\nDescription:\nThe Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor. The Regulatory Affairs Manager II may have to take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their Portfolio director.\nThe Regulatory Affairs Manager II is fully proficient in applying established standards to perform regulatory affairs management for moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates in continuous improvement of process and tools/systems.\nRegulatory Affairs Management\nContributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements to GRET and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.\nProvides regulatory labeling expertise and leads the maintenance of global labeling documents for Established brands. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products, including USPIs and other regional labeling.\nAccountabilities/Responsibilities:\nRegulatory Affairs Management\nUnderstands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.\nProvides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:Submission delivery strategy of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals.\nProvide scientific contribution to single documents such as PSRs, response documents, , regulatory maintenance documents Risk Management Plans, , Addendum to Clinical and NonClinical Overview, Pharmacovigilance agreement (PVA), Core labelling documentation (e.g. Company Core Data Sheets, USPI, EUQRD and Core Safety Profiles), etc.\nAnalysis of regulatory procedures and special designations used during development, authorization and extension of the product.\n\nUses and shares best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.\nLeads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions\nLiaise closely with cross-functional members with aligned product responsibilities.\nDevelops, executes and maintains submission delivery plans, submission content plans using digital tools like Veeva Vault (ERV) and compliance, and proactively provides status updates to designated stakeholders.\nCoordinates the input, maintenance and revision in the project planning tools for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.\nIdentifies regulatory risks and proposes mitigations to Lead RPM and cross functional teams.\nSupports operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.\nProvides coaching, mentoring and knowledge sharing within the regulatory organization.\nContributes to process improvement.\nUse available AI tools effectively and responsibly to improve efficiency, streamline routine activities, and support high-quality regulatory deliverables\nMinimum Requirements -Education and Experience\nRelevant University Degree in Science or related discipline\nMinimum 8+ years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development\nThorough knowledge of the regulatory product maintenance process\nStrong project management skills\nLeadership skills, including experience leading multi-disciplinary project teams.\nPreferred Experience\nThe US Regulatory affairs experience\nManaged regulatory deliverables at the project level\nExperience of working with people from locations outside of India, especially Europe and/or USA\nSkills and Capabilities\n· Excellent English written and verbal communication skills\n· Cultural awareness\n· Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions\n· Proficiency with common project management (e.g., MS Project) and document management tools\n· Basic understanding of emerging technologies like AI, ML etc\n· Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning\n· Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.\n· Ability to work independently and as part of a team\n· Influencing and stakeholder management skills\n· Ability to analyze problems and recommend actions\n· Continuous Improvement and knowledge sharing focused\nInternal and External Contacts/Customers\nGlobal Regulatory Leads (GRLs)\nRegulatory Regional Leads (eg, US, EU, International RADs)\nLead RPM\nOther R & D skill groups, eg, Clinical, Clinical Operations, GRO, Labeling, Reg CMC, Operations regulatory, Patient Safety, Regulatory Central, GRL, Regional Leads. Operations/Manufacturing organization (CMC post approval)\nMarketing Companies/Local affiliates\nHealth Authorities\nExternal collaboration partners\nReporting Relationship\n· Direct Reports - None\n· Indirect Reports -None\nWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. To fully experience our collaborative, in-person environment, candidates who are not currently based in the job location will need to relocate. In line with our company policy, relocation support is offered for moves within the country, ensuring a smooth transition.\nJoin us in our unique and ambitious world.\nWhy AstraZeneca:\nHere, your regulatory expertise directly shapes how our medicines reach patients. We bring unexpected teams into the same room to unleash bold thinking, challenge assumptions, and craft innovative data packages that earn the best possible labels. You will operate at pace, influence strategy early, and collaborate across modalities while adopting new technologies and automation to drive efficiency. It is a supportive environment where we value kindness alongside ambition, encourage curiosity, and empower quick decisions-so you can stretch your skills, grow your career, and see your impact on approvals that matter.\nWhere Can I Find Out More?\nOur Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/\nCall to Action:\nIf you are ready to lead global maintenance submissions, elevate labels, and accelerate patient impact, step forward and join us to make a measurable difference now!\nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.\nDate Posted\n08-Oct-2026Closing Date\n31-Oct-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.","description_format":"text","description_chars":9557,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":true}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Prescription Drugs","Oncology Therapeutics","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-08T11:44:23Z"}],"visa":[],"liveness":{"score":40,"band":"fade","label":"Fading","p_open":1,"p_active":0.536,"p_room":0.75,"age_days":17,"expected_fill_days":20,"reasons":["conf:0","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-ii","json_url":"https://alion.io/job/astrazeneca-regulatory-affairs-manager-ii.json","meta":{"generated_at":"2026-10-27T04:09:59Z","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":3615,"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":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-ii"},{"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-ii"},{"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-ii"},{"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-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastrazeneca-regulatory-affairs-manager-ii"}]}