{"id":3887105,"url":"https://alion.io/job/interdot-regulatory-affairs-pharmacist","title":"Regulatory Affairs Pharmacist","company":{"id":4521405,"name":"Interdot","domain":"interdot.co.za","url":"https://alion.io/company/interdot-co-za","size_band":"1001-5000","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Manatal","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-11-06T19:59:04Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T10:09:56Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"QUALIFICATIONS NEEDED:\nBachelors Degree in Pharmacy or Diploma in Pharmacy.\nNECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:\n3 to 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent.\nThorough knowledge of the current Medicines and Related Substances Act, the current Pharmacy Act and current regulatory policies and guidelines of SAHPRA and their implication to the company.\nExperience in Pharmaceutical Regulatory Affairs aspects (Medicine registration (eCTD) and legal compliance) and documentation management and product maintenance related to the product portfolio.\nWorking knowledge of Pharmaceutical Manufacturing related legislation\nKnowledge of marketing code of practice.\nExperience in registering product in ZAZIBONA.\nExperience in having faced successfully local and/ or international quality audits.\nExperience in eCTD compilation (Extedo.)\nKEY DUTIES & RESPONSIBILITIES OF THE ROLE:\nMaintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by: -\nReceiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines to support the strategic business objectives and close any compliance gaps as quickly as possible.\nPreparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.\nPerform due diligence audits of existing and new product regulatory dossiers.\nCompile and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.\nCompletion of applicable Section 36 Exemption, Section 21, and Clinical Trial Applications.\nUpdate and maintain dossiers to latest requirements\nIdentify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.\nEnsure product licence and retention fees are paid on time.\nProvide regulatory advice and support when required to relevant stakeholders including but not limited to sales, marketing, supply chain, medical and commercial, S&I, projects team with regards to the products.\nAssist RA Manager in follow ups / responses on regulatory audits by third party / NRA.\nRegulatory Intelligence: Assist RA Manager to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Companys products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.\nRequest and obtain Import & Export Permits.\nWriting / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per the QA calendar.)\nProvide guidance in opening and close out of Change Controls/ NCRs / CAPAs to support QAs processes.\nReview and approve artwork for packaging material to ensure compliance with regulatory requirements.\nMaintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the companys applications when required.\nEnsure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence.\nApprove promotional material (advertising) when required.\nAssist in establishing the annual regulatory budget.\nOn request from the Responsible Pharmacist, (in the absence of the Regulatory Affairs Manager), Deputise as the Responsible Pharmacist in the absence of the Responsible Pharmacist","description_format":"text","description_chars":3965,"description_truncated":false,"requirements":{"experience_years_min":3,"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":["Pharmacies"],"lifecycle":[{"event":"open","at":"2026-11-06T19:59:04Z"}],"visa":[],"liveness":{"score":54,"band":"ok","label":"Likely open","p_open":1,"p_active":0.542,"p_room":1,"age_days":1,"expected_fill_days":27,"reasons":["conf:3","agency","velocity","win:early","comp:brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":null,"html_url":"https://alion.io/job/interdot-regulatory-affairs-pharmacist","json_url":"https://alion.io/job/interdot-regulatory-affairs-pharmacist.json","meta":{"generated_at":"2026-11-08T12:27:50Z","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":26521,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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":4521405},"rest":"https://alion.io/mcp/rest/get_company?id=4521405"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Finterdot-regulatory-affairs-pharmacist"},{"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%2Finterdot-regulatory-affairs-pharmacist"},{"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%2Finterdot-regulatory-affairs-pharmacist"},{"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/interdot-regulatory-affairs-pharmacist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finterdot-regulatory-affairs-pharmacist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3887105}},{"tool":"search_jobs","arguments":{"company":"interdot.co.za","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3887105},"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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