Pharmaceutical Regulatory Affairs Professional
2 days ago
We are seeking a highly experienced Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This role involves developing regulatory strategies and implementation plans for the preparation and submission of new products, focusing on complementary medicines and medical devices. You will 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. In addition, you will prepare registration applications for submission to the regulatory authorities, work in collaboration with internal and external stakeholders to assess regulators' submissions requirements, and ensure maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations, and guidelines for variations (CMC & Labelling), Renewals, Artwork updates, etc.
Key Responsibilities:
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 include experience in use of CTD software builder and compilation of eCTD dossier applications. IT skills including Microsoft Office. Ability to prioritize 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.
Requirements:
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.
-
Midrand, Gauteng, South Africa Emporium Full timeEmporium seeks a highly skilled Regulatory Affairs Pharmacist to spearhead our OTC product development and commercialization efforts in South Africa.Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Demonstrate responsibility, excellence and collaboration and align with Company values.Key Job...
-
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 Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeEmporium is seeking a skilled Regulatory Affairs Specialist to join our team in Midrand. This role offers a unique opportunity to leverage your expertise in pharmaceutical regulations and compliance.Job Overview:The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and allocating resources. They will also...
-
Regulatory Affairs Pharmacist
2 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...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeAt Emporium Human Capital, we are seeking a skilled Regulatory Affairs Specialist to oversee the compliance of our pharmaceutical products.Salary: R900,000 - R1,000,000 per annumKey Responsibilities:Manage work streams for assigned portfolio of products, including internal and external queriesEstablish regulatory priorities and allocate resources and...
-
Regulatory Affairs Specialist
2 months ago
Midrand, Gauteng, South Africa Jordan HR Full timeAt Jordan HR, we are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our pharmaceutical products with regulatory requirements.This role involves extensive experience in regulatory affairs, preferably in human medicines, including complementary...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital. This role will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products.About the Role:The successful candidate will have a strong background in regulatory affairs, preferably in human medicines,...
-
Regulatory Affairs Director
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeEmporium Human Capital is seeking a highly skilled Regulatory Affairs Director to lead our OTC division's regulatory activities and develop a comprehensive regulatory strategy.The ideal candidate will have a strong background in pharmaceutical regulatory affairs, with at least 8 years of experience and a B. Pharm degree. They should be registered with...
-
Midrand, Gauteng, South Africa Emporium Human Capital Full timeAbout the RoleThis is an exciting opportunity for a Regulatory Affairs Pharmacist to take on a challenging role in a dynamic environment.The successful candidate will have a strong background in pharmacy, with experience in regulatory affairs and project management.A sound understanding of pharmaceutical regulations and quality systems is essential for this...
-
Regulatory Affairs Manager
2 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 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 Strategist
2 months ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob SummaryAs a Regulatory Affairs Strategist at Emporium Human Capital, you will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. You will adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation...
-
Regulatory Affairs Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeSenior Regulatory Affairs Pharmacist Position at Emporium Human CapitalJob Summary:We are seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our pharmaceutical development and compliance team, you will be responsible for managing work streams, reporting on assigned portfolios of...
-
Regulatory Affairs Director
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Overview:We are seeking a highly experienced and strategic Regulatory Affairs Director to join our team at Emporium Human Capital. This is an exceptional opportunity for a skilled professional to drive regulatory compliance and strategy across our pharmaceutical division.About the Role:As a key member of our leadership team, the Regulatory Affairs...
-
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 Full timeSeeking a seasoned Regulatory Affairs Specialist to lead the development and commercialization of pharmaceutical products in compliance with regulatory standards. Salary: R950,000 - R1,000,000 per annum About the Role:As a key member of our team, you will be responsible for managing work streams, reporting on assigned portfolios of products, and...
-
Regulatory Affairs Director
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob DescriptionThe Head of Regulatory Affairs is responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.Key ResponsibilitiesAdopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies as...
-
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 Human Capital Full timeOverviewElevate your career in regulatory affairs with a leading position at Emporium Human Capital. We are seeking a Senior Regulatory Affairs Pharmacist to join our team, bringing expertise in OTC products and a passion for compliance.
-
Pharmaceutical Regulatory Manager
2 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeEmporium Human Capital is seeking a Pharmaceutical Regulatory Manager to join our team in Midrand. The ideal candidate will have a strong background in regulatory affairs, preferably in human medicines, and a minimum of 5 years of experience in the field.The successful candidate will be responsible for managing work streams, establishing regulatory...
