Regulatory QA(Responsible Pharmacist)

2 weeks ago


Johannesburg, Gauteng, South Africa ES Recruitment Full time

Minimum Requirements:

  • Must have Matric / Grade 12
  • B. Pharm degree.
  • Registered with the South African Pharmacy council.
  • At least 2-3 years regulatory experience.
  • Experience in compilation and submission of Act 101 (SAHPRA) Dossiers.
  • Thorough understanding of GMP.
  • Must be computer literate (MS Word, Excel and PowerPoint, intermediate to advanced skills required).
  • High accuracy and attention to detail skills.
  • Strong work ethic.

The following would enhance your position and will be an advantage:

  • Previous Quality Assurance Management experience.
  • Experience as a Responsible Pharmacist in a Manufacturing environment.
  • Experience in compilation and submission of Act. 36 Dossiers.
  • Animal Health industry experience.
  • Knowledge of regulatory submissions in Zimbabwe, Namibia & Zambia.
  • Pharmaceutical Production knowledge.
  • CTD submission experience will be an advantage

Main Accountabilities:

  • Act as Responsible Pharmacist for the entity
  • Regulatory Strategy & intelligence.
  • Responsible for the Regulatory Plan and the successful execution thereof.
  • Dossier preparation, compliance checks & submissions.
  • LOQ Answer, submission & interaction with authorities.
  • Maintenance & product life cycle management.
  • Knowledge and intelligence management.
  • Right level of quality & strategy.
  • Quality Management System& strategy.
  • Community building and activation.
  • Responsible for Pharmacovigilance.
  • Audits & inspections.
  • Product release.
  • CAPA identification and implementation.
  • Deviation and non-conformance management.
  • Annual Product quality review management.
  • Legal Compliance with Act. 101 & Act. 53


  • Johannesburg, Gauteng, South Africa JorDan Human Resources Full time

    Permanent CT00417 Medical, Pharmaceutical & Nursing Gauteng, JHB Northern Suburbs R R 58000 Monthly Cost To Company (Standard Benefits ) Pharmaceutical Production Client in JHB North in need of a Regulatory Affairs Pharmacist, to ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable) Ensure compliant...


  • Johannesburg, Gauteng, South Africa ES Recruitment Full time

    Summary of position:Regulatory:Responsible for:- preparation of good quality dossiers and submissions according to specified timelines, in designated countries, to ensure earliest registrations and approvals.- preparation, review, and approval of product labeling.- review and approval of product promotional materials.- management of local pharmacovigilance...


  • Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 72665Job Type PermanentJob Title Regulatory Affairs PharmacistComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province Gauteng Reporting To Regulatory Affairs Manager / Senior RA PharmacistJob Purpose To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of...


  • Johannesburg, Gauteng, South Africa Kasha Ltd Full time

    Role Title: Responsible Pharmacist & Quality Assurance Manager About Kasha: Kasha is a fast-growing purpose-driven start-up company in East and South Africa focused on women's health and personal care, selling products such as menstrual care, contraceptives, HIV self-tests, soaps, lotions, baby diapers, and beauty products. Kasha's eCommerce is highly...


  • Johannesburg, Gauteng, South Africa Curiska Full time

    JOB TITLE: Regulatory Affairs PharmacistCOMPANY: Pharmaceutical CompanyDESCRIPTION: Join our team as a Regulatory Affairs Pharmacist to ensure a smooth product registration process and compliance with all regulations. Your role involves overseeing regulatory documentation, managing safety updates, and maintaining pharmacovigilance requirements.DUTIES AND...


  • Johannesburg, Gauteng, South Africa ARIAD Full time

    Head of Regulatory Affairs, Responsible Pharmacist:Johannesburg, GautengJob ID R0118346Category Research & DevelopmentSubcategory Research & DevelopmentBusiness Unit Global Portfolio DivisionJob Type Full time Title:_ Head of Regulatory Affairs, Responsible Pharmacist Location:__Johannesburg, South Africa__office._ Field: Regulatory and Quality_About...

  • Regulatory Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa PSM Personnel Full time

    Regulatory Pharmacist RegulatoryJohannesburg North-GautengOur client, one of the leaders in the pharmaceutical industry is looking to hire a Regulatory Affairs Pharmacist to support the Regulatory Affairs function with both pre and post registration and dossier submission activities by assisting in data gathering, screening, collating, and compiling of the...


  • Johannesburg, Gauteng, South Africa Takeda Pharmaceutical Full time

    Title:_ Head of Regulatory Affairs, Responsible Pharmacist Location:_ __Johannesburg, South Africa_ _office._ Field: Regulatory and Quality_About TakedaAt Takeda we strive to broaden access to treatment and enhance standards of care for people wherever they live. We focus on sustainably strengthening local health systems in low- and middle-income countries...


  • Johannesburg, Gauteng, South Africa Servier Full time

    Date posted:28 Feb 2024City:JohannesburgCountry/Region:ZAType of Contract:PermanentJob Requisition ID:5374Regulatory Affairs Pharmacist- .REGULATORY AFFAIRS PHARMACISTJOB OVERVIEW**: Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain Servier's...

  • Regulatory Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa Immploy Recruitment Full time

    REGULATORY ACTIVITIES:Delivery of annual product submission planCompiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC.Due diligence on prospective dossiers from third-party companies.Delivery of Future RegistrationsContinuous liaison with SAHPRA to ensure...


  • Johannesburg, Gauteng, South Africa Yolundi Talent Solutions Full time

    To fulfil the position as Responsible Pharmacist for Cospharm Investments (Pty) Ltd in South AfricaCompany Compliance: To be responsible for overall company compliance to SAPC/SAHPRA/DOH legislation. To ensure that the applicant operates in accordance with the provision of the Medicines and Related Substances Control Act, the Pharmacy Act and other...


  • Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES: Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist Ensure and supervise that...

  • Regulatory Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa Yolundi Talent Solutions Full time

    To fulfil the position as Regulatory Affairs Pharmacist for Cospharm Investments (Pty) Ltd aCompany Compliance: To be responsible for overall company compliance to SAPC/SAHPRA/DOH legislation. To ensure that the applicant operates in accordance with the provision of the Medicines and Related Substances Control Act, the Pharmacy Act and other applicable...

  • QA Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa Divergent Recruit Full time

    JOB ALERT - NEW VACANCYPOSITION: QUALITY ASSURANCE PHARMACISTLOCATION:FLORIDA, JOHANNESBURGMINIMUM ESSENTIAL QUALIFICATIONS: Matric Bachelor of Pharmacy Degree Valid Registration with SAPC (ESSENTIAL) Minimum of 35 years' post qualification working experience in a pharmaceutical environment with QA experience Working experience in the following: Release of...

  • Ra/qa Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa Measured Ability Group Holdings Full time

    South Africa - Gauteng, Johannesburg - North (Sandton / Midrand / Diepsloot)****R R800 000Our Pharmaceutical client is looking for a RA/QA Pharmacist to join their Animal Health division.Key requirements B. Pharm degree with at least 2 years of experience in compilation of new dossier and variations to SAHPRA Experience in dealing with the department of...


  • Johannesburg, Gauteng, South Africa MNA Recruitment Full time

    A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.Key Responsibilities: Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries. Ensure the completion of submissions/ variations...


  • Johannesburg, Gauteng, South Africa Johnson & Johnson Full time

    REGULATORY AFFAIRS PHARMACISTLocation: GautengContract: PermanentThe responsibilities & the impact YOU will have:SummaryTo effectively complete all required Regulatory tasks relating to product registrations and dossierlifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to ensure these tasks are performed in...


  • Johannesburg, Gauteng, South Africa Prostaff Holdings Full time

    Minimum requirements for the role:A B Pharm degree registered with South African Pharmacy Council is essential for this role.Previous experience having worked in a Responsible Pharmacist role having worked closely with SAHPRA is essential for the role.Previous experience having managed and handled all regulatory aspects within a pharmaceutical manufacturing...


  • Johannesburg, Gauteng, South Africa Zoie Health Full time

    About ZoieZoie Health is Africa's first digital women's health clinic. Zoie's mission is to make quality women's healthcare more accessible for millions of women around the world by leveraging leading technology, world-class clinical care and love. Our vision is for Zoie to be part of a woman's healthcare journey for life, as we care for her and her loved...

  • QA Release Pharmacist

    2 weeks ago


    Johannesburg, Gauteng, South Africa Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands.Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...