Regulatory Affairs Pharmacist

2 weeks ago

Johannesburg, South Africa Servier Full time

**Date posted**:28 Feb 2024**City**:Johannesburg**Country/Region**:ZA**Type of Contract**:Permanent**Job Requisition ID**:5374Regulatory Affairs Pharmacist
- .**REGULATORY AFFAIRS PHARMACIST**

**JOB **OVERVIEW**:

- 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 RESPONSIBILITIES**:

- Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
- Provide input to the regulatory strategy in-line with business objectives
- Detailed understanding of regulatory guidelines and technical requirements
- Manage and implement safety updates where required
- Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations
- To ensure approval and compliance of printed packaging material and promotional marketing material.
- License renewals with service providers i.e. SAHPRA, South African Pharmacy Council (SAPC)
- Writing and developing of SOP in line with Global SOP’s
- Manage internal and external audits (i.e.Global & SAHPRA)
- Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation
- Manage of product complaints and deviations
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality related records are available and retained.
- Co-ordinate product recall or market withdrawal when necessary
- Obtain and distribute updated information on domestic and international laws
- Report ADR to Global Safety and SAHPRA
- Follow-up of Adverse Drug Reactions (ADRs),
- Pharmacovigilance training of local staff
- Answering of requests from the Regulatory Authority with cooperation with Global Safety
- MINIMUM REQUIREMENTS:
- Education:
- B. Pharm (Bachelor of pharmacy)
- Registration with the South African Pharmacy Council (SAPC)
- Job Training and Experience:
- Minimum 5 years’ experience in Regulatory Affairs - (must have human medicine experience and biologicals)
- Experience in Product registration (NCE)
- Maintenance of dossiers and updating thereof
- Pharmacovigilance experience/knowledge of collecting and reporting
- Knowledge of SAHPRA submission portals
- Launch procedures for new products
- Knowledgeable and experienced regarding QA processes, APQRs, customer complaints etc.
- In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management.
- Knowledge of the Marketing Code
- Systems knowledge:
- Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
- Familiar with ZAZIBONA processes
- Competent and experienced in eCTD submissions.
- INDISPENSIBLE QUALITIES:
- Focus
- Attention to detail
- Flexibility
- Planning and organisation
- Communication
- Teamwork
- Confidentiality
- Agile and able to work in a fast pace
- Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.- At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

  • Regulatory Affairs Pharmacist

    1 week ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72665 **Job Type** - Permanent **Job Title** - 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** - To Support the Regulatory Affairs team with...

  • Regulatory Affairs Pharmacist

    3 days ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72882 **Job Type** - Permanent **Job Title** - 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** - To Support the Regulatory Affairs team with...

  • Regulatory Affairs Pharmacist

    6 days ago

    Johannesburg, South Africa Stafflink Recruitment Solutions Full time

    **Minimum Requirements**: Bachelors 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 medicines - minimum 5 years of experience. Experience in registration of products and regulatory knowledge on South Africa, Botswana, Namibia, Mauritius,...

  • Senior Regulatory Affairs Pharmacist

    2 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...

  • Regulatory Affairs Pharmacist

    18 hours 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...

  • Snr Regulatory Affairs Pharmacist

    2 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...

  • Regularity Affairs Pharmacist

    3 days ago

    Johannesburg, South Africa RPO Recruitment Full time

    RPO Recruitment is a trusted recruitment agency specializing in finding top talent in the field of regulatory affairs within the pharmaceutical industry. Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Pharmacist to join their team. As a Regulatory Affairs Pharmacist, you will play a vital role in ensuring compliance with...

  • Head of Regulatory Affairs, Responsible Pharmacist

    3 days ago

    Johannesburg, South Africa ARIAD Full time

    **Head of Regulatory Affairs, Responsible Pharmacist**: Johannesburg, Gauteng **Job ID** R0118346 **Category** Research & Development **Subcategory** Research & Development **Business Unit** Global Portfolio Division **Job Type** Full time - Title:_ Head of Regulatory Affairs, Responsible Pharmacist - Location:_**_Johannesburg, South...

  • Regulatory affairs pharmacist

    3 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...

  • Regulatory affairs pharmacist

    2 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

    2 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

    3 weeks ago

    Johannesburg, South Africa Jordan HR Full time

    Ensure compliant and timeous processing of regulatory submissions and commitments as assigned.Bachelor of PharmacyMinimum 1 year Regulatory Affairs experience but significant QA experience in pharma environmentComputer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems.Entry Level position to Support...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, South Africa Jordan HR Full time

    Ensure compliant and timeous processing of regulatory submissions and commitments as assigned.Bachelor of PharmacyMinimum 1 year Regulatory Affairs experience but significant QA experience in pharma environmentComputer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems.Entry Level position to Support...

  • Regularity Affairs Pharmacist

    3 weeks ago

    Johannesburg, South Africa RPO Recruitment Full time

    RPO Recruitment is a trusted recruitment agency specializing in finding top talent in the field of regulatory affairs within the pharmaceutical industry. Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Pharmacist to join their team.As a Regulatory Affairs Pharmacist, you will play a vital role in ensuring compliance with...

  • Regulatory Affairs Officer

    2 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...

  • Senior Regulatory affairs pharmacist

    2 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...

  • Snr Regulatory Affairs Portfolio Manager

    3 weeks ago

    Johannesburg, South Africa Abbott Laboratories Full time

    **About Abbott** Abbott 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 yourself and family, be your true self and live a full...

  • Snr Regulatory Affairs Portfolio Manager

    3 weeks ago

    Johannesburg, South Africa Abbott Full time

    The Opportunity This position works out of our Roodepoort Offices, Abbott Place in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across...

  • Senior Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, South Africa Adzuna ZA B C2 Full time

    Position Summary and Objective:Responsible for the regulatory management of South Africa and some Southern African markets like Botswana and Namibia for an allocated part of the companys generic portfolio of products. Future markets and portfolios of products could be included as well as regulatory harmonization occurs.Provide oversight for assigned...

  • Senior Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, South Africa Stafflink Recruitment Solutions Full time

    Position Summary and Objective: Responsible for the regulatory management of South Africa and some Southern African markets like Botswana and Namibia for an allocated part of the companys generic portfolio of products. Future markets and portfolios of products could be included as well as regulatory harmonization occurs. Provide oversight for assigned...