Regulatory Affairs Specialist

3 weeks ago

Johannesburg, South Africa Ultra Personnel Full time

Health Sciences Degree is essential
5 - 10 years' experience in the pharmaceutical industry
3 - 5 years in Regulatory Affairs
Good working knowledge of MS Office (Excel, Word, Adobe Pro, Power point, etc.) and Outlook***
Create, update, submit and maintain product dossier registration documentation in accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submission plans and to develop and maintain timelines.
Develop and maintain current regulatory knowledge.
Acquire published new or amended acts, regulations, bills and notices relevant to the industry.
Identify Standard Operating Procedures (SOP) and documentation that may be affected by new or amended legislation.
Convey the implications of new legal requirements to the Responsible Pharmacist and Head of Regulatory.
Supply technical information and registration support to the relevant departments and identify deviations from legislation and recommend corrective action.
Ensure that current Good Manufacturing Practice is maintained for all processes and products.
Collect all the information and specifications required for dossier compilation.
Collect technical information relating to finished products during New Product Development and to be part of the New Product Development process.
Write clear, accessible product labels, professional information, and patient information leaflets.
Ensure that Quality standards are maintained during dossier creation and propose improvements.
Provide thoughtful and accurate comments during document review mindful of regulatory requirements.
Finalise and present to an RA Pharmacist or the Responsible Pharmacist a completed dossier in the required format for final approval.
Perform regulatory audits on product dossiers.
Perform peer reviews on colleagues dossiers.
Migrate to and maintain dossiers on the DocuBridge system.
Review all master documentation sent for approval by third party manufacturers.
Ensure the regulatory compliance, and approve, artwork and marketing material according to the relevant Standard Operating Procedures.
Initiate and facilitate change control process in according to the relevant Standard Operating Procedure.
Assist with the initiation and monitoring of product stability testing and data, and incorporation into dossiers, when required.
Assist with the adverse drug reaction and pharmacovigilance processes within the department
Assist with customer enquiries where required.
Be certified with the Marketing Code Authority and advise relevant departments on the requirements.
Without detracting from specific tasks and duties referred to in the job description, comply with any reasonable requests or instructions from the Responsible Pharmacist and Head of Regulatory related to company functions from time to time.

  • Regulatory Affairs Specialist

    4 weeks ago

    Johannesburg, South Africa iProcess Global Research Inc Full time

    JOB SUMMARY ESSENTIAL DUTIES Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2024-01-23 - 2024-02-06 - Permanent - CT004178 - Medical, Pharmaceutical & Nursing- Gauteng, JHB - Northern Suburbs - R 55000 - 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...

  • Regulatory Affairs Systems Associate

    4 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 68543 **Job Type** - Permanent **Job Title** - Regulatory Affairs Systems Associate **Computer Skills** - MS Excel,Adobe Acrobat **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems,...

  • Junior Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72214 **Job Type** - Permanent **Job Title** - Junior Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - Entry Level position to Support the...

  • Director, Legal

    4 weeks ago

    Johannesburg, South Africa Onafriq Full time

    We are recruiting for a Director, Legal & Regulatory Affairs to join the Governance, Risk and Compliance team at Onafriq. This role will be responsible for managing the legal and regulatory affairs function and through their team will provide (a) legal advice and guidance across the Group, and (b) manage the Group’s regulatory agenda and engagements with...

  • Regulatory Affairs Officer

    7 days ago

    Johannesburg, South Africa B. Braun Medical (Pty) Ltd. Full time

    B. Braun Medical Pty Ltd based in Johannesburg, South Africa require the services of a Regulatory Affairs Officer to be based at our Head Office in Northriding, Johannesburg. B. Braun is a leading medical device and pharmaceutical company, which currently has more than 63,000 employees globally, and offices and production facilities in more than 60...

  • Junior Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2024-01-23 - 2024-02-06 - Permanent - CT004179 - Medical, Pharmaceutical & Nursing- Gauteng, JHB - Northern Suburbs - R 40000 - R 41000 Monthly Cost To Company (Standard Benefits )- Pharmaceutical manufacturing client in JHB north in need of a Junior Regulatory Pharmacist, to ensure compliant and timeous processing of regulatory submissions and prioritise...

  • Regulatory Affairs Pharmacist

    6 days ago

    Johannesburg, 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...

  • Senior Regulatory Affairs Pharmacist

    7 days ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs - Annually Cost To Company (Market related) Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist. **SKILLS & QUALIFICATIONS**: - Bachelor’s degree in Pharmacy, registered with the South African Pharmacy Council - MSc, MBA or PhD may be an advantage. - Experience in regulatory...

  • Senior Specialist: Regulatory Affairs

    1 week ago

    Johannesburg, South Africa Network Recruitment Full time

    Key Responsibilities: Act as a central point of contact with Financial Services sector regulators, ensuring the timely collation and submission of information. Support the Senior Manager in identifying, escalating, and managing regulatory risks. Maintain an understanding of the legislation affecting the Group, to provide support and solutions. Foster...

  • Senior Regulatory Affairs Manager

    4 weeks ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs - Annually Cost To Company (Market related) Well established Pharmaceutical business seeking to appoint a Senior Regulatory Affairs Manager **Minimum Requirements**: - B Pharm or Related Scientific Degree - M Pharm an advantage but not a requirement - Regulatory Affairs Pharma Industry - 10+ years’ experience, of at least...

  • Regulatory affairs pharmacist

    3 weeks ago

    Johannesburg, South Africa Adzuna ZA B C2 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 affairs pharmacist

    3 weeks ago

    Johannesburg, South Africa Curiska 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 affairs pharmacist

    4 weeks ago

    Johannesburg, 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...

  • Snr Regulatory Affairs Pharmacist

    5 days ago

    Johannesburg, South Africa Hire Resolve Full time

    Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client's team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.Responsibilities Prepare and submit regulatory applications for the registration of...

  • Snr Regulatory Affairs Pharmacist

    3 weeks ago

    Johannesburg, South Africa Servier Full time

    . Servier Laboratories Snr Regulatory Affairs Pharmacist JOB OVERVIEW: As a Snr Regulatory Affairs Pharmacist your responsibility for ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain Servier’s pharmacovigilance requirements. DUTIES AND...

  • Regulatory Affairs Head

    8 hours ago

    Johannesburg, South Africa GSK Full time

    **Site Name**: South Africa - Gauteng - Johannesburg **Posted Date**: May 13 2024 **Job Purpose**: Lead the regulatory team responsible for the South African Market, to ensure access to medicines, contributing to growth and profitability of GSK business, protecting reputation and ensuring regulatory compliance in the market, in alignment with local...

  • Senior Regulatory Affairs Manager

    4 weeks ago

    Johannesburg, South Africa Six Sense Consulting Full time

    **Minimum Requirements**: - B Pharm or Related Scientific Degree - M Pharm an advantage but not a requirement - Regulatory Affairs Pharma Industry - 10+ years experience, of at least 5 years management experience - SAPC Registered Pharmacist **Key Knowledge and Skills required**: - Relevant Acts, Regulations, and guidelines that governs the Pharmaceutical...

  • Regulatory Affairs Manager

    4 weeks ago

    Johannesburg, South Africa Emporium Human Capital Full time

    Regulatory Affairs Manager (Critical Care) POS24104Aeroton/ Crown minesR 900 000 per annumPURPOSE OF THE JOB Lead 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. To ensure legal compliance with the relevant...

  • Senior Regulatory affairs pharmacist

    3 weeks ago

    Johannesburg, South Africa Curiska 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...