Regulatory Affairs Manager

2 weeks ago


Johannesburg, Gauteng, South Africa Unique Personnel Full time

Job Number

  • 72786

Job Type

  • Permanent

Job Title

  • Regulatory Affairs Manager

Computer Skills

  • Ms Office

Industry

  • Manufacture

City

  • Johannesburg (Incl. Northern Suburbs)

Province

  • Gauteng

Reporting to Head:
Regulatory Affairs


Job purpose:

  • Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.

Key Job Outputs

  • Manage work streams for
- and report on the assigned group of portfolios

  • Assisting with internal product queries from relevant departments
  • Assisting with external product queries from the SAHPRA, other MRA's and thirdparty stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
  • Conduct dossier due diligence to ensure all data gaps are addressed
  • Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
  • Internal training and mentoring
  • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
  • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Manage activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company values
    Inherent Requirements

Qualifications/Experience

  • Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • Minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards

Core competencies

  • IT skills
  • Leadership skills
- management of personnel resources

  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem solving and decisionmaking skills
  • Customer relationships
  • Development of people
  • Must demonstrate responsibility, excellence and collaboration and align with Company values

What Qualification

  • Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

Minimum Qualification

  • Bachelors

Status

  • Available


  • 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 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 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...

  • 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 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 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 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 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 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 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 Boston Scientific Corporation Full time

    Work mode:HybridOnsite Location(s):Johannesburg, South AfricaAdditional Locations: South Africa-Johannesburg; Bucharest-Romania; Lebanon-Beirut; Turkey-IstanbulDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...


  • 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...