Senior Regulatory Affairs Pharmacist Complimentary Medicine Specialist
2 months ago
Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team.
Key Responsibilities:- Manage work streams for- and report on the assigned portfolio of products
- 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
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- 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
- 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
- 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
- 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
-
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineWe are seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our complementary medicine products.Key...
-
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineWe are seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our complementary medicine products.Key...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineEmporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of products:Internal product queries from relevant departmentsExternal product...
-
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team. As a key member of our regulatory affairs department, you will be responsible for managing work streams, reporting on assigned portfolios, and establishing regulatory...
-
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine 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...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Senior Regulatory Affairs Pharmacist Complimentary MedicineAbout the Role: We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities: Manage work streams for- and report on the assigned portfolio of products:Internal product queries from relevant departmentsExternal product queries from the SAHPRA, other...
-
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. The successful candidate will be responsible for managing work streams for assigned portfolios of products, including internal and external product queries, and establishing regulatory priorities and allocating resources and workloads.Key...
-
Regulatory Affairs Pharmacist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a Senior Regulatory Affairs Pharmacist for Complementary Medicines, you will be responsible for managing work streams, establishing regulatory priorities, and allocating resources and workloads.Key Responsibilities:Manage work streams for-...
-
Regulatory Affairs Pharmacist
2 months ago
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team in the Complementary Medicine department. As a Senior Regulatory Affairs Pharmacist, you will be responsible for managing work streams, reviewing regulatory agency submissions, and coordinating the submission of new product applications in South Africa and other...
-
Senior Regulatory Affairs Pharmacist: OTC
2 months ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist: OTCEmporium 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 ensuring compliance with regulatory requirements for our OTC medicines.Key Responsibilities:Manage work streams for- and report on the...
-
Senior Regulatory Affairs Specialist
1 week ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Senior Regulatory Affairs PharmacistJob Summary:We are seeking a Senior Regulatory Affairs Pharmacist to manage work streams for- and report on the assigned portfolio of products. The ideal candidate will have a degree in pharmacy, experience in regulatory affairs, and strong project management skills.Key Responsibilities:Establish regulatory...
-
Pharmaceutical Regulatory Specialist
1 week ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeKey ResponsibilitiesManage work streams for- and report on assigned portfolios of products, including internal and external queriesEstablish regulatory priorities and allocate resources and workloadsReview agency submissions to ensure accuracy and compliance with standardsCoordinate and submit new product applications to regulatory authoritiesCore...
-
Regulatory Affairs Specialist
1 week 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...
-
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 Pharmacist 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.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
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeRegulatory Affairs PharmacistEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key Responsibilities:Manage work streams for- and report on the...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeRegulatory Affairs Pharmacist RoleEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team in Midrand. 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 Responsibilities:Develop and...
-
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 human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...
-
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 human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...
-
Regulatory Affairs Specialist
3 weeks 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...
