{"id":2954521,"url":"https://alion.io/job/hikma-pharmaceuticals-regulatory-affairs-associate","title":"Regulatory Affairs Associate","company":{"id":1843927,"name":"Hikma Pharmaceuticals","domain":"hikma.com","url":"https://alion.io/company/hikma","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cherry Hill, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":58000,"max_usd":122000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":132},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Ruby","optional":false}],"status":"live","first_seen_at":"2026-09-21T00:00:00Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-11-02T02:52:46Z","board_verified":true,"closed_at":null,"days_open":42,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":42},"description":"Job Title: Regulatory Affairs Associate\nJOB PRUPOSE\nResponsible for ongoing support of regulatory activities, including preparation and submission of Annual Reports, Annual Product Reviews, foreign registrations, change controls and labeling review and proofreading. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to any deficiency letters.\nRESPONSIBILITIES\nReviews and approves labeling for revisions to current products.\nProofreads labeling drafts as requested by labeling.\nDrafts revised labeling (Package Inserts) for marketed products based on FDA requirements and/or Hikma proposed changes.\nCompletes regulatory portion of Annual Product Reviews (APRs).\nReviews change control requests and provides regulatory opinion with supervisor concurrence.\nSupports the collection of documents for foreign registration, including submitting requests to FDA for Certificate of Pharmaceutical Product.\nProvides regulatory support to teams and gives updates at regulatory staff meetings, as needed.\nPrepares and submits Annual Reports, supplements, amendments, and other correspondences to FDA.\nKeeps Hikma’s Ruby database current for all injectable products.\nQUALIFICATIONS\nExercise independent judgment.\nScientific knowledge.\nWritten and Verbal communication skills.\nStrong Negotiation skills.\nExtremely strong accuracy and attention to detail.\nAbility to work independently, be flexible and accommodating as priorities may change.\nTechnical system skills (e.g. word processing, spreadsheets, databases, online research).\nManage multiple projects and deadlines.\nAbility to identify compliance risks and escalate when necessary.\nEDUCATION AND/OR EXPERIENCE\nBS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellent\ncommunication skills is required. Two (2) years of regulatory exposure is preferred.\nWhat We Offer\nClean climate-controlled working environment\nAnnual performance bonus potential\n401k employer match up to 6% of your contributions\n23 vacation/personal days\n11 paid Company holidays\nGenerous healthcare benefits\nEmployee discount program\nWellbeing rewards programs\nSafety and Quality is a top organizational priority\nCareer advancement/growth opportunities\nTuition Reimbursement\nMaternity and Parental Leave\n*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.","description_format":"text","description_chars":2581,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["401k plan","Growth opportunities","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Generic Drugs","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-20T21:04:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 20 · green card filings: 7","filings_12m":20,"filings_prev_12m":15,"green_card_filings_12m":7,"median_offered_wage_usd":105093,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.165,"p_room":0.28,"age_days":41,"expected_fill_days":7,"reasons":["conf:3","win:tail","crowd:junior"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/hikma-pharmaceuticals-regulatory-affairs-associate","json_url":"https://alion.io/job/hikma-pharmaceuticals-regulatory-affairs-associate.json","meta":{"generated_at":"2026-11-02T03:38:24Z","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":5511,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":1843927},"rest":"https://alion.io/mcp/rest/get_company?id=1843927"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhikma-pharmaceuticals-regulatory-affairs-associate"},{"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%2Fhikma-pharmaceuticals-regulatory-affairs-associate"},{"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%2Fhikma-pharmaceuticals-regulatory-affairs-associate"},{"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/hikma-pharmaceuticals-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhikma-pharmaceuticals-regulatory-affairs-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2954521}},{"tool":"search_jobs","arguments":{"company":"hikma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2954521},"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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