Regulatory Affairs Pharmacist
2 weeks ago
Regulatory Affairs Pharmacist (CC) – POS24329
Area: Aeroton
Salary R900 – R1m
Qualifications
- Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
- +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
- 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
- Good Manufacturing Practices (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge.
Key Job Outputs
- Manage work streams for- and report on the assigned portfolio of products:
- Internal product queries from relevant departments
- External product queries from the SAHPRA, other MRA’s and third-party 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
- Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
- Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
- Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
- Prepare the registration applications for submission to the regulatory authorities
- 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 for variations (CMC & Labelling), Renewals, Artwork updates etc.
- Update and maintain databases, trackers and systems for all regulatory related activities.
- Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal training and mentoring of peers when required.
- 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.
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values
- Core competencies
- Experience in use of CTD software builder and compilation of eCTD dossier applications.
- IT skills including Microsoft Office
- 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 decision-making skills
- Customer relationships
- Development of people
- Must demonstrate responsibility, excellence and collaboration and align with Company values
Closing Date: 31 October 2024
To apply for this position: Send MS Word format CV to jobs@emporium.co.za and use POS24329 – Snr RA Pharma CC in the subject line
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg South, South Africa Emporium Full timeRegulatory Affairs Pharmacist (POS24323)Area; AerotonSalary R750 – 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg South, South Africa Emporium Full timeRegulatory Affairs Pharmacist (POS24323)Area; AerotonSalary R750 – 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (POS24323)Area; AerotonSalary R750 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
4 months ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
3 months ago
Johannesburg South, South Africa Emporium Full timeRegulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 – 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
3 months ago
Johannesburg South, South Africa Emporium Full timeRegulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 – 800kPurpose of the role: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 outputs. To ensure legal compliance with the relevant medicine Regulatory...
-
Regulatory Affairs Pharmacist
4 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 72989 **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
4 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...
-
Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, South Africa The Vine Partners Full timeJob Title: Regulatory Affairs PharmacistLocation: Johannesburg, GautengSalary: R62,000 - R67,000 per monthAbout the Role:We are seeking a skilled and detail-oriented Regulatory Affairs Pharmacist to join our client's team. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with...
-
Senior Regulatory Affairs Pharmacist
4 months ago
Johannesburg, South Africa PSM Personnel Full timeSenior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications/experience - Bachelors Degree or Diploma in Pharmacy with the South African Pharmacy Council registration. - +-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end...
-
Regulatory Affairs Specialist
6 days ago
Johannesburg South, South Africa The Vine Partners Full timeJob Title: Pharmacist Regulatory AffairsWe are seeking a highly skilled Pharmacist Regulatory Affairs professional to join our team at The Vine Partners.Key Responsibilities:Regulatory Affairs Management: Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory authorities.Regulatory...
-
Regulatory Affairs Pharmacist
3 months ago
Johannesburg, South Africa Johnson & Johnson Full timeWe 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...
-
Lead Regulatory Affairs Pharmacist
3 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeJOB TITLE: Lead Regulatory Affairs PharmacistCOMPANY: CuriskaDESCRIPTION: We are seeking a dedicated Lead Regulatory Affairs Pharmacist to join our esteemed organization. In this pivotal role, you will be responsible for facilitating the product registration process and ensuring adherence to all regulatory standards. Your expertise will be crucial in...
-
Junior Regulatory Affairs Pharmacist
4 months 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...
-
Regulatory Affairs Specialist
16 hours ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs PharmacistAbout the Role:We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for human medicines, including complementary medicines and medical devices.Key...
-
Regulatory Affairs Specialist
5 days ago
Johannesburg South, South Africa Emporium Full timeRegulatory Affairs PharmacistEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.About the Role:The successful candidate will support the Regulatory team in providing superior Regulatory services to relevant departments within the company and with external partners and Principals. They will ensure legal compliance with the...
-
Regulatory Affairs Pharmacist
3 months ago
Johannesburg, South Africa Six Sense Full timeGauteng, 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,...
-
Regulatory Affairs
4 months ago
Johannesburg, South Africa Mass Staffing Projects Full time**Job Information** - Location- Manufacturing Jobs in Johannesburg- Salary- R940k - R720k- Job Type- Permanent- Education- B.Pharm- Experience- 3+ Years- Reference- RAPHARM9- - pharmacy.jobs(at)staffingprojects.co.za- Fax- 0866023398MSP Recruitment is currently recruiting for a Multinational Pharmaceutical organisation based in Johannesburg, who seeks to...
-
Regulatory Affairs Pharmacist Specialist
7 days ago
Johannesburg, Gauteng, South Africa The Vine Partners Full time{"title": "Regulatory Affairs Pharmacist", "description": "Job SummaryWe are seeking a skilled Regulatory Affairs Pharmacist to join our client\u2019s team at The Vine Partners. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards, and overseeing submissions...
-
Regulatory Affairs Pharmacist
6 days ago
Johannesburg, Gauteng, South Africa Curiska Full timeJob OverviewCuriska is seeking a highly skilled Regulatory Affairs Pharmacist to ensure seamless product registration and dossier maintenance. The ideal candidate will have a deep understanding of regulatory guidelines and technical requirements, as well as excellent leadership and management skills.Key ResponsibilitiesProvide strategic direction and lead...