Regulatory Affairs

2 weeks ago


Johannesburg, Gauteng, South Africa LA Medical Recruitment Specialists Full time
Bachelor of Pharmacy Degree, Postgraduate (PHD/MBA) an advantage. Qualification in Medical Device & EHS Regulations preferred. 3 years experience in Regulatory & Quality Assurance in Pharma or Medical device environment. 3 -5 years experience at executive management level.

Knowledge of medical and pharmaceutical products and services; legal requirements impacting on regulatory/quality i.e.

advertising, trade and metrology, GMP, GLP, GCP, GDP, GVP, ISO 13485, ISO 9001etc; Knowledge of all appropriate laws regarding manufacturing, testing, distribution, advertising of Medicinal Products and Medical Devices; pharmacology and therapeutics; operations i.e.

quality assurance, quality control and manufacturing.

Regulatory Responsibilities:

Ensure compliance to any applicable national requirements for the distribution of Medicinal Products and Medical Devices in the respective markets.

Establish and maintain a management system according to the national requirements. Identify and implement effective processes and procedures for accomplishing compliance to documented CAPA's.

Plan, manage and control the day-to-day execution of regulatory affairs activities and drive improvement. Maintain adequate records of registration activities and track registration submissions and approvals.

Keep up to date with respect to new legislation in countries of responsibility and advise the company on the impact of new legislation on current business.

Develop strategies and systems to remain compliant locally and that are in line with Region requirements. Establish and maintain relationships with the MOH's, distributors, and key role players in the industry. Establish regulatory compliance regarding the sale of non-registered medicines.

Sales and Marketing Support:
Assist with developing and managing project plans.

Management of the Quality Assurance:
Qualification of contract manufactures, critical suppliers or service providers. Creation and maintenance of Quality Assurance Agreements with contract manufacturer, critical suppliers or service providers. Creation and maintenance of supplier evaluation. Oversee QA functions are conducted compliantly to company policies and procedures and government regulations. Performance, administration and documentation of annual self-inspections. Performance of mock recalls.

Ensure the activities are in compliance to the Technical Agreements entered into the Regional Hub SA.

Ensure the compilation and implementation of documents required in order to remain compliant with the local regulators as per the local published and current acts and regulations, for the business continuity of Pharmaceutical and Medical device products.

Packaging compliance and transition in the requirements to remain compliant to the region and practical for local system requirements and legislation.


Ability to commute/relocate:

  • Johannesburg, Gauteng: Reliably commute or planning to relocate before starting work (required)


  • 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 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 Unique Personnel Full time

    Job Number 71064Job Type PermanentJob Title Regulatory Affairs PharmacistComputer Skills Adobe Acrobat,MS ExcelIndustry ManufactureCity JohannesburgProvince Gauteng Reporting to RA Systems ManagerJob purpose Maintain applicable regulatory affairs information management electronic systems, ensuring accurate system usage and data integrity by all stakeholders....


  • Johannesburg, Gauteng, South Africa PSM Personnel Full time

    Head of Regulatory Affairs Pharmacist ~ RegulatoryJohannesburg North-GautengWe are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you will...


  • Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 71851Job Type PermanentJob Title Head of Regulatory AffairsComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting To Managing Director - company OTCJob Purpose The Head of Regulatory Affairs holds ultimate responsibility for the company OTC division's regulatory activities and oversees the...


  • 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...

  • Regulatory Affairs

    2 weeks ago


    Johannesburg, Gauteng, South Africa Danone Full time

    About the jobManage all Regulatory Affairs and Category Compliance activities on behalf of Danone Nutricia Africa (DNAF) for Southern Africa & export countries within the scope of Specialized Nutrition (SN) division: baby food products and medical nutrition.Protect and support Danone's business and assets by designing and implementing the optimal regulatory...


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

    The Head of Regulatory Affairs ZA will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support local GPH regulatory team as required striving for convergence in ways of working.The position may also have Local QP responsibility.Reports to: Direct line to Managing Director ZA Dotted to Snr Director...


  • Johannesburg, Gauteng, South Africa Novo Nordisk AS Full time

    Are you passionate about driving changes and improvements? Do you want to be a part of a fast-growing and developing company that is dedicated to helping people? If so, we have an exciting opportunity for you to join Novo Nordisk as a Regulatory Affairs Portfolio Manager. Take the chance and embark on this rewarding career journey!This position will be based...


  • Johannesburg, Gauteng, South Africa Thermo Fisher Scientific Full time

    PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve healthWe are vital links between an idea for a new medicine and the people who need it.We are...


  • Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    Exciting Opportunity at Novo Nordisk: Regulatory Affairs Portfolio ManagerLocation: Johannesburg, South AfricaReporting to: Head of Regulatory Affairs & PharmacovigilanceAbout the Position:Monitor local regulatory environment and ensure complianceCompile, submit, and approve NDA, Medical Devices, and LCM licensesReview and approve promotional...


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

    We are currently hiring a Regulatory Affairs Pharmacist for our South African office, to be based in Johannesburg in a hybrid work model.Teamwork at the organization will help you grow with world-class training, as well as our educational programs and the opportunities they offer.Key Responsibilities: Effectively complete all regulatory tasks from new...


  • Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    Are you passionate about driving changes and improvements?Do you want to be a part of a fast-growing and developing company that is dedicated to helping people?If so, we have an exciting opportunity for you to join Novo Nordisk as a Regulatory Affairs Portfolio Manager.Apply today and join us for a life-changing careerThis position will be based in...


  • Johannesburg, Gauteng, South Africa Ultra Personnel Full time

    Essential Skills and Experience RequiredQualifications: B. Pharm Degree Registration with South African Pharmacy Council, MS or PhD in life sciences or related field is required.A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industryMinimum of 5 years in...


  • Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 72786Job Type PermanentJob Title Regulatory Affairs ManagerComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting to Head: Regulatory AffairsJob purpose: Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners...


  • Johannesburg, Gauteng, South Africa Abbott Laboratories Full time

    Job TitleRegulatory Affairs Specialist (1-Year Fixed-Term Contract)About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for...


  • 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...


  • Johannesburg, Gauteng, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs Annually Cost To Company (Market related)Well established Pharmaceutical business seeking to appoint a Regulatory Affairs Pharmacist.Minimum Requirements: Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage Experience in regulatory affairs, preferably in human...


  • 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 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...