Head of Regulatory Affairs
Found in: Whatjobs ZA C2 - 5 days ago
Head of Regulatory Affairs (POS24078)
R 1,8mill per annum
Based in Midrand
BEE Candidates only to apply
Job Purpose:
The Head of Regulatory Affairs holds ultimate responsibility for the RX DIVISIONS regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.
- Requirements Qualifications:
- To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations
- Qualifications: B. Pharm Degree Registration with South African Pharmacy Council.
- A minimum of 8 years pharmaceutical regulatory experience is an absolute prerequisite.
- Minimum of 5 years in people or team management is required.
- This role requires a high degree of networking & collaboration both within and outside the organization.
- Demonstrated experience across the product development, commercialization and dossier maintenance lifecycle
Key Job Outputs
- Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
- Adopts a risk-based assessment for all regulatory submissions and anticipates potential issues for risk mitigation strategies to be in place.
- Anticipates future regulatory changes and impacts on business success.
- Communicates to ensure an excellent understanding of Regulatory Affairs
- Pays strict attention to details and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining sense of urgency.
- Strives to maintain a high level of quality. Ensures superior execution by combining the best practices of regulatory.
- Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/ Packaging, Stability and Research & Development, where proactive input can then enhance operation efficiency.
- To give information and input to Responsible Pharmacist in order to facilitate appropriate decision making in order to ensure that all SAHPRA requirements are timeously met.
- Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal Training, Development and Mentorship to the Rx RA Managers
- 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.
- Manage activities such as internal audits or regulatory agency inspections.
- Manages a team in the Relicare India Team
- To collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.
Closing Date: 30 April 2024
-
Head of Regulatory Affairs
3 days ago
Midrand, South Africa JorDan Human Resources Full time2023-11-13 - 2023-11-23 - Permanent - CT004124 - Medical, Pharmaceutical & Nursing- Gauteng, Midrand - R 1500000 - R 1550000 Monthly Cost To Company (Standard Benefits )- Pharmaceutical Manufacturing and Distribution Client in JHB North in need of a Head of Regulatory Affairs to ensure legal compliance with the relevant Health Regulatory Authorities, country...
-
Head of Regulatory Affairs
Found in: Talent ZA 2A C2 - 2 weeks ago
Midrand, South Africa Emporium Human Capital Full timeHead of Regulatory Affairs (POS24078)R 1,8mill per annumBased in MidrandBEE Candidates only to applyJob Purpose:The Head of Regulatory Affairs holds ultimate responsibility for the RX DIVISIONS regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.Requirements Qualifications:To ensure legal...
-
Regulatory Affairs Pharmacist
3 days ago
Midrand, South Africa MSD Full timeOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the...
-
Senior Regulatory Affairs Pharmacist
Found in: Talent ZA 2A C2 - 2 weeks ago
Midrand, South Africa Jordan HR Full time- 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, commercialization and maintenance lifecycle- Sound project management capabilities - Proven ability to consistently...
-
Senior Regulatory Affairs Pharmacist
Found in: Whatjobs ZA C2 - 5 days ago
Midrand, South Africa Jordan HR Full time- 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, commercialization and maintenance lifecycle- Sound project management capabilities - Proven ability to consistently...
-
Associate Director, Regulatory Affairs
Found in: beBee S ZA - 4 weeks ago
Midrand, South Africa MSD Full timeJob DescriptionMajor Activities Major activities include, but are not limited to:New MA applications for assigned products:Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs...
-
Government Affairs and Policy Analyst Intern
2 days ago
Midrand, South Africa ITrain Full timePolicy Analyst and Executive Assistant: Sub-Saharan Africa Seeking an intern who has a relevant qualification and has some experience as a Government Affairs and Policy Analyst to take part in a 12-month internship and a well-known, multinational medical company. Main Duties and responsibilities are to: - Monitor and report on regional, national and...
-
Managing Executive: Group Public Policy
7 days ago
Midrand, South Africa Vodafone Full time**Role purpose**: As a member of the Vodacom Group External Affairs leadership team to: Provide counsel and advice on regulatory and public policy opportunities and risks facing Vodacom Group operating companies. Proactively manage public policy and regulatory risks by influencing outcomes through strategic advocacy. Establish and maintain strategic...
-
Regulatory Legal and Compliance
Found in: Talent ZA C2 - 2 days ago
Midrand, South Africa Deloitte Full timeJob DescriptionWe are looking for experienced professionals in regulatory and compliance. Your role will be to focus on the delivery of client engagements, share knowledge and experience with others and understand the objectives for clients and align your own work to objectives.Ongoing advisoryReporting to client Head of ComplianceExecuting on legislative...
-
Medical Advisor
2 days ago
Midrand, South Africa Ellahi Consulting Full timeContribute to the Medical Affairs activities in the country - in interaction with Regional Medical Affairs. **Location**: Midrand, Johannesburg **Education and Experience**: - Bachelor degree in Medicine required, with Microbiology Pathology qualification highly preferred. - Minimum 3 years continuous clinical experience in a hospital setting. - Minimum 5...
-
Associate Clinical Research Manager
2 days ago
Midrand, South Africa MSD Full timeWith support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...
-
Executive Head
7 days ago
Midrand, South Africa Vodafone Full time**Role purpose**: To consider and evaluate selected merger and acquisition opportunities and to evaluate selected disinvestments on behalf of Vodacom Operating companies in the rest of the continent. In addition, to act as a corporate advisor (current & new) to the Vodacom Group by providing in-house corporate finance advisory services. **Your...
-
Head of Credit
2 days ago
Midrand, South Africa Buzzing Careers Full time**Job Specification: Head of Credit** **Location: Midrand** **Reporting line into the COO** **Languages**:English required, Afrikaans beneficial **About the Company**: Our client forms part of a large diversified group. They are a leading financial services provider specializing in equipment finance. They are dedicated to building lasting relationships...
-
Clinical Operations Manager
6 days ago
Midrand, South Africa MSD Full timeThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. Clinical Operations Manager, Head COMs or...
-
Clinical Research Manager
2 weeks ago
Midrand, South Africa MSD Full timeThis role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...
-
Senior Clinical Operations Manager
6 days ago
Midrand, South Africa MSD Full timeThis role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company's policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on study operational activities and for out-tasking as applicable....
-
Executive Head: Wholesale Mobile
3 days ago
Midrand, South Africa Vodafone Full time**Role purpose**: **National **Roaming**: To craft and execute national roaming strategy keeping abreast with the latest technological advancements, industry regulation and the competitive landscape of the ICT sector in South Africa. - ** Defend Revenue**:The incumbent shall be responsible for retaining current roaming revenue with National MNOs. - ** Grow...
-
Executive Secretary
3 days ago
Midrand, South Africa Vodafone Full time**Role purpose**: Provide secretarial and administrative support to the ME: Regulatory Affairs & Public Policy team and key stakeholders. Including streamlining activities, outputs, and outcomes in the office of the ME Regulatory Affairs & Public Policy (RA&PP). **Your responsibilities will include**: **General accountabilities**: Manage the diary, mailbox...
-
Head: Communication, Marketing,
7 days ago
Midrand, South Africa DBSA Full timeThe Head: Communications, Marketing & Events (CME) is responsible for all facets of DBSA’s brand, product marketing and communications. The Head is accountable for the DBSA’s CME strategies, planning and implementation thereof. In charge of increasing the DBSA’s coverage and awareness of the Bank’s strategic objectives and projects through...
-
Executive Head: VSA Pricing and Governance
Found in: beBee S ZA - 4 weeks ago
Midrand, South Africa Vodafone Full timeWhen it comes to putting people first, we're number 1. The number 1 Top Employer in South Africa. Certified by the Top Employer Institute 2024.Role purpose:As the Head of Pricing at Vodacom South Africa, you will be responsible for overseeing all aspects of pricing strategy, revenue optimization, and profitability for the organization's products and...