Snr Regulatory Affairs Pharmacist

2 weeks ago

Johannesburg, South Africa Servier Full time

**Date posted**:23 Apr 2024**City**:Johannesburg**Country/Region**:ZA**Type of Contract**:Permanent**Job Requisition ID**:5902Snr Regulatory Affairs Pharmacist
- .**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 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 co-operation 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 experience 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.

  • Snr Regulatory Affairs Pharmacist

    Found in: Talent ZA C2 - 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...

  • Regulatory Affairs Pharmacist

    2 days 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...

  • Snr Regulatory Affairs Portfolio Manager

    Found in: Talent ZA C2 - 2 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...

  • Regulatory Affairs Pharmacist

    4 days ago

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

    B. Braun Medical Pty Ltd based in Johannesburg, South Africa requires the services of a Regulatory Affairs Pharmacist to be based at our Head Office in Northriding. 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 countries. Its...

  • Regulatory affairs pharmacist

    Found in: Talent ZA 2A C2 - 1 week 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

    Found in: Talent ZA C2 - 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

    Found in: Adzuna ZA B C2 - 1 week 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...

  • Head of Regulatory Affairs

    4 days ago

    Johannesburg, South Africa PSM Personnel Full time

    Head of Regulatory Affairs Pharmacist ~ Regulatory Johannesburg North-Gauteng We 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...

  • Regulatory Pharmacist

    3 days ago

    Johannesburg, South Africa Yolundi Talent Solutions Full time

    To fulfil the position as Regulatory Affairs Pharmacist for Cospharm Investments (Pty) Ltd a Company 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...

  • Regulatory Affairs Pharmacist

    Found in: Talent ZA 2A C2 - 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...

  • Regulatory Affairs Pharmacist

    Found in: Whatjobs ZA C2 - 6 days 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

    Found in: Talent ZA C2 - 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...

  • Senior Regulatory affairs pharmacist

    Found in: Whatjobs ZA C2 - 6 days 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 Specialist

    7 days 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...

  • Head of Regulatory Affairs

    4 days ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71851 **Job Type** - Permanent **Job Title** - Head of Regulatory Affairs **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting To Managing Director - company OTC** **Job Purpose** - The Head of Regulatory Affairs holds ultimate responsibility...

  • Senior Regulatory Affairs Pharmacist

    Found in: Whatjobs ZA C2 - 6 days 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...

  • Senior Regulatory Affairs Pharmacist

    Found in: Adzuna ZA B C2 - 1 week 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

    Found in: Talent ZA 2A C2 - 3 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...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, South Africa Kumusa Consulting Full time

    To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African **Required Learning/Experience** - Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council - Minimum of 1-3 years experience in...

  • Regulatory & Public Affairs Officer

    4 days ago

    Johannesburg, South Africa Connect Recruit Full time

    **Overview**: This is a position reports to the organisation’s CEO. The incumbent will have overall responsibility for regulatory, policy and public affairs initiatives within the private equity and venture capital industry. The position will require regular interaction with a wide range of stakeholders including private equity firms, international...