[3 Days Left] Regulatory Affairs Pharmacist
2 months ago
Regulatory Affairs Pharmacist (OTC) POS24326
Area: Midrand
Salary R900 R1m
Qualifications
- Bachelors 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 MRAs 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 regulators 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
-
Regulatory Affairs Pharmacist Professional
7 days ago
Midrand, Gauteng, South Africa Jordan HR Full timeJob TitleSenior Regulatory Affairs PharmacistAbout Jordan HRJordan HR is a reputable organization seeking a highly skilled and experienced Senior Regulatory Affairs Pharmacist to join our team.Job SummaryWe are looking for a seasoned professional with expertise in regulatory affairs, pharmaceutical production experience, and excellent IT skills. The ideal...
-
Regulatory Affairs Pharmacist
1 month ago
Midrand, South Africa Jobted ZA C2 Full timeRegulatory Affairs Pharmacist (OTC) POS24328 Area: Midrand Salary R900 R1m Qualifications - Bachelors 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...
-
Regulatory Affairs Pharmacist
4 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Regulatory Affairs PharmacistJob Summary: We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios, and ensuring regulatory compliance.Key Responsibilities:Manage work streams for assigned portfolios of...
-
Regulatory Affairs Pharmacist
2 months ago
Midrand, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (OTC) POS24328 Area : Midrand Salary R900 R1m Qualifications Bachelors 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...
-
Regulatory Affairs Pharmacist
2 months ago
Midrand, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (OTC) POS24328Area: MidrandSalary R900 R1mQualificationsBachelors 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...
-
Regulatory Affairs Pharmacist Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of productsEstablish regulatory priorities and allocate resources and workloadsReview regulatory agency submission of materials to ensure...
-
Regulatory Affairs Pharmacist Specialist
7 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our Complimentary Medicine Division, you will play a critical role in ensuring compliance with regulatory standards.Salary: R900,000 - R1,000,000 per annumAbout the Role:We are looking for an experienced Regulatory Affairs Pharmacist to...
-
Regulatory Affairs Pharmacist Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Manage work streams for assigned portfolios of products and report on progress.Assist with internal and external product queries from relevant departments and regulatory authorities.Establish...
-
Regulatory Affairs Pharmacist
2 months ago
Midrand, South Africa Emporium Full timeRegulatory Affairs Pharmacist (OTC) – POS24328Area: MidrandSalary R900 – R1mQualificationsBachelor’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...
-
Regulatory Affairs Pharmacist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our organization, you will be responsible for managing work streams, establishing regulatory priorities, and ensuring compliance with regulatory standards.Key Responsibilities:Manage work streams for...
-
Regulatory Affairs Pharmacist
2 months ago
Midrand, South Africa Emporium Full timeRegulatory Affairs Pharmacist (OTC) – POS24328Area: MidrandSalary R900 – R1mQualificationsBachelor’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...
-
Regulatory Affairs Manager
6 months ago
Midrand, South Africa Cipla Full time**Department**: Regulatory Affairs **Employment Type**: Full-time **Job Purpose**: - Manage submissions to different Health Authorities within the Regulatory Affairs function by ensuring targets are met each financial year - Manage registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and...
-
Regulatory Affairs Pharmacist
1 month ago
Midrand, South Africa Jobted ZA C2 Full timeRegulatory Affairs Pharmacist OTC POS24203 Based: Midrand Salary: R750K Qualifications/experience - Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council - 3 to 5 years experience in Regulatory Affairs, preferably in human medicines - Demonstrable experience across the product development,...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Senior Regulatory Affairs Pharmacist: Pain, Derma Job Reference: POS24205 Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist: Pain, Derma to join their team. As a key member of the Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements for...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. The ideal candidate will have a strong background in regulatory affairs, with experience in human medicines, including complementary medicines and medical devices.Key Responsibilities:Manage end-to-end regulatory...
-
Regulatory Affairs Pharmacist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistCompany: Emporium Human CapitalJob Summary: We are seeking a highly skilled Regulatory Affairs Pharmacist to manage work streams, report on assigned portfolios, and establish regulatory priorities.Key Responsibilities:Manage internal and external product queries from relevant departments and regulatory...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Senior Regulatory Affairs Pharmacist with OTC ExpertiseJob Summary: We are seeking a highly skilled Senior Regulatory Affairs Pharmacist with expertise in OTC products to join our team at Emporium Human Capital.This role involves managing work streams and reporting on assigned portfolios of products, establishing regulatory priorities, and...
-
Regulatory Affairs Pharmacist
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Regulatory Affairs PharmacistEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for managing work streams, establishing regulatory priorities, and allocating resources and workloads.Key Responsibilities:Manage work streams for- and report on...
-
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist: Pain, DermaEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage internal and external...
-
Regulatory Affairs Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeRegulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for pharmaceutical products, ensuring compliance with relevant laws and regulations.Collaborate with cross-functional teams to ensure regulatory requirements are met...
