Regulatory Affairs Pharmacist: Pain, Derma and Medicines
1 month ago
Job Summary:
">We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a talented professional to leverage their expertise in regulatory affairs, pain management, and dermal medicines to drive business growth and success.
">About the Role:
">The successful candidate will be responsible for managing work streams, reporting on assigned portfolios, and ensuring timely submission of new product applications. They will also establish regulatory priorities, allocate resources, and review agency submissions to ensure compliance with regulatory standards.
">In addition, they will conduct dossier due diligence, prepare registration applications, and maintain databases and trackers for regulatory activities. The ideal candidate will have excellent communication and project management skills, with the ability to prioritize tasks and work to tight deadlines.
">Key Responsibilities:
">- ">
- 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">
- 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, 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">
About Us:
">Emporium Human Capital is a leading recruitment agency providing exceptional talent solutions to businesses across various industries. Our mission is to empower individuals and organizations to achieve their full potential by connecting them with top talent and innovative recruitment strategies.
">What We Offer:
">We offer a competitive salary package, including R950 000 - R1 million per annum, depending on experience. If you are a motivated and experienced Regulatory Affairs Pharmacist looking for a new challenge, please submit your application with your resume and cover letter.
-
Regulatory Affairs Pharmacist: Pain, Derma Expert
2 months ago
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...
-
Pain, Derma Regulatory Affairs Expert
5 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our team, you will be responsible for ensuring compliance with regulatory standards and developing regulatory strategies for the preparation and submission of new products.Your expertise in regulatory affairs,...
-
Senior Regulatory Affairs Pharmacist
2 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeAbout the RoleWe are seeking a seasoned Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The ideal candidate will have extensive experience in human medicines, including complementary medicines and medical devices, with a strong background in regulatory affairs.As a key member of our regulatory team, you will be responsible...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob DescriptionAs a Senior Regulatory Affairs Pharmacist at Emporium Human Capital, you will be responsible for managing work streams and reporting on assigned portfolios of products. Your expertise in regulatory affairs, including human medicines and complementary medicines, will ensure compliance with regulatory standards.We are seeking a highly skilled...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Overview:We are seeking a seasoned Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This role will be responsible for managing work streams, reporting on assigned portfolios, and ensuring regulatory compliance across human medicines and complimentary medicines.Key Responsibilities:Manage internal product queries from relevant...
-
Regulatory Affairs Pharmacist Professional
1 month 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 Specialist
2 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob DescriptionThis is a senior Regulatory Affairs role for a Regulatory Affairs Pharmacist Specialist to manage regulatory activities for pharmaceutical products. The successful candidate will be responsible for ensuring compliance with relevant regulations and guidelines.Main ResponsibilitiesManage work streams for- and report on the assigned portfolio of...
-
Regulatory Affairs Specialist
2 months 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...
-
Senior Regulatory Affairs Pharmacist
5 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Summary Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. The ideal candidate will have experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices. Key Responsibilities: Manage work streams for- and report on the assigned...
-
Regulatory Affairs Specialist
2 months 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 Pharmacist Specialist
1 month 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
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our pharmaceutical compliance team, you will play a critical role in ensuring the registration and maintenance of our products in accordance with regulatory requirements.About the RoleThis is an exciting opportunity for a...
-
Regulatory Affairs Pharmacist Expert
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a motivated and experienced professional to take on a key role in ensuring the compliance and registration of pharmaceutical products.About the RoleThis position involves managing work streams, reviewing...
-
Regulatory Affairs Pharmacist
2 months 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 Manager
5 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full time**Regulatory Affairs Specialist Wanted!We're Emporium Human Capital, a leading recruitment agency in South Africa, and we're looking for an experienced Regulatory Affairs Pharmacist to join our team!**About the Job:This is a fantastic opportunity to utilize your expertise in Regulatory Affairs to drive business success.You'll develop and implement regulatory...
-
Regulatory Affairs Specialist
2 months ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (OTC) RoleLocation: MidrandSalary: R900 - R1mQualifications:Bachelor's Degree in Pharmacy with Registration with the South African Pharmacy Council5+ years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activitiesDemonstrable...
-
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
2 months 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...
-
Regulatory Affairs Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a seasoned professional to leverage their expertise in human medicines, including complementary medicines and medical devices, to drive end-to-end regulatory activities.About the RoleThis role involves...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeAbout the Role Emporium Human Capital is a leading recruitment agency in South Africa, and we are excited to offer this unique opportunity for a Senior Regulatory Affairs Pharmacist to join our team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for managing work streams for- and reporting on the assigned portfolio of products. You...
