Regulatory Affairs Director
3 weeks ago
Job Summary:
The Head of Regulatory Affairs will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. This role requires a high degree of networking and collaboration both within and outside the organisation.
Key Responsibilities:
- Adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies, as applicable.
- Anticipate, communicate and manage future regulatory changes and impacts on business success.
- Communicate to ensure an excellent understanding of Regulatory Affairs.
- Pays strict attention to detail 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 regulatory practices.
- Represent RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research & Development.
- Assist the launch team in order to facilitate smooth launch process in line with product and dossier compliance.
- 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.
- 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 an off-site Regulatory Affairs support team.
- Collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.
- Ensure Group Stability Department adheres to applicable regulations and company procedures.
- Represent Group Stability Department in cross-functional decision-making discussions and Management Escalation and Reporting.
Requirements:
- B. Pharm Degree
- Registration with South African Pharmacy Council
- A minimum of 8 years of pharmaceutical regulatory experience
- A minimum of 5 years in people or team management
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa CA Financial Appointments Full timeRegulatory Affairs DirectorCA Financial Appointments is seeking a seasoned Regulatory Affairs Director to join our team in the financial services sector. This key role reports directly to the Head of Public Policy and Regulatory, and is responsible for managing all regulatory and compliance developments and affairs.Responsibilities:Ensure the company's...
-
Regulatory Affairs Director
1 month ago
Midrand, Gauteng, South Africa Jordan HR Full timeJordan HR is seeking a highly skilled and experienced Regulatory Affairs Manager to join our team. The ideal candidate will have a strong background in pharmaceutical regulatory affairs and a proven track record of leading cross-functional teams. Key responsibilities include: **Qualifications** * Bachelor of Pharmacy degree with registration with the South...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa The Recruitment Council Full timeThe Recruitment Council is seeking a highly skilled Regulatory Affairs Director to oversee compliance with financial regulations and industry standards. As a senior member of our team, you will report to the Head of Public Policy and Regulatory and be responsible for ensuring our organization's understanding and adherence to evolving regulatory...
-
Regulatory Affairs Director
2 months ago
Midrand, Gauteng, South Africa Jordan HR Full timeJordan HR is seeking a highly skilled and experienced professional to fill the role of Head of Regulatory Affairs Manager. The ideal candidate will possess a strong background in pharmaceutical regulatory affairs and have a proven track record of leading cross-functional teams to drive collaboration, innovation, and operational excellence. Key...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob SummaryThe Head of Regulatory Affairs will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. This role requires a high degree of networking and collaboration both within and outside the organisation.Key ResponsibilitiesDrives the regulatory...
-
Head of Regulatory Affairs Director
2 months ago
Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full timeHead of Regulatory Affairs Job DescriptionMNA Recruitment (Pty) Ltd is seeking a highly skilled and experienced Head of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the Regulatory Affairs Division and overseeing the development and delivery of a fully integrated regulatory strategy for the business.Key...
-
Regulatory Affairs Director
4 weeks ago
Midrand, Gauteng, South Africa Jordan HR Full timeJordan HR is seeking a seasoned professional to fill the role of Head of Regulatory Affairs Manager. **Qualifications and Experience** To be successful in this position, you will need to have a B. Pharm degree and registration with the South African Pharmacy Council. A minimum of 8 years of experience in pharmaceutical regulatory affairs is required,...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeKey ResponsibilitiesDevelop and execute regulatory strategies to ensure compliance with relevant laws and regulations.Lead the development and maintenance of regulatory policies and procedures.Collaborate with cross-functional teams to ensure regulatory requirements are met.Manage regulatory risks and develop mitigation strategies.Represent the company in...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeAbout the RoleThe Head of Regulatory Affairs is a key position within Emporium, responsible for ensuring compliance with all relevant regulations and guidelines in the pharmaceutical industry. This role involves developing and implementing regulatory strategies to support business objectives, as well as managing the regulatory aspects of product launches and...
-
Regulatory Affairs Manager
2 months ago
Midrand, Gauteng, South Africa Hire Resolve Full timeJob Title: Regulatory Affairs ManagerHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains...
-
Regulatory Affairs Specialist
2 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 Manager
2 weeks ago
Midrand, Gauteng, South Africa Set Consulting Full timeJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Set Consulting. As a key member of our Public Policy and Regulatory Affairs team, you will be responsible for managing all regulatory and compliance developments and affairs for the company, ensuring our understanding and adherence to relevant financial regulations,...
-
Regulatory Affairs Manager
3 weeks ago
Midrand, Gauteng, South Africa SET Recruitment Consultants Full timeAt SET Recruitment Consultants, we are seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for managing all regulatory and compliance developments and affairs for the company, ensuring adherence to relevant financial regulations, laws, and industry guidelines.Key Responsibilities:Ensure the...
-
Regulatory Affairs Manager
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeKey ResponsibilitiesThe Head of Regulatory Affairs will oversee the development and delivery of a fully integrated regulatory strategy for the business, ensuring compliance with relevant Health Regulatory Authorities, the Medicines and Related Substances Control Act 101 of 1965, and the South African Pharmacy Act (Act 53 of 1974).Key AccountabilitiesDevelop...
-
Head of Regulatory Affairs
1 month ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Head of Regulatory AffairsEmporium Human Capital is seeking a highly skilled and experienced Head of Regulatory Affairs to join our team.About the Role:The Head of Regulatory Affairs will be responsible for overseeing the regulatory activities of the OTC division and developing a fully integrated regulatory strategy for the business. This role...
-
Head of Regulatory Affairs
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Head of Regulatory AffairsEmporium is seeking a highly skilled and experienced Head of Regulatory Affairs to lead our OTC division's regulatory activities and develop a fully integrated regulatory strategy for the business.Key Responsibilities:Oversee the development and delivery of a regulatory strategy for the OTC divisionEnsure legal compliance...
-
Head of Regulatory Affairs
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Head of Regulatory AffairsEmporium is seeking a highly skilled and experienced Head of Regulatory Affairs to lead our OTC division's regulatory activities and develop a fully integrated regulatory strategy for the business.Key Responsibilities:Oversee the development and delivery of a regulatory strategy for the OTC divisionEnsure legal compliance...
-
Regulatory Affairs Strategist
2 weeks 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 Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring seamless product registration and dossier maintenance, while ensuring compliance with all regulations and pharmacovigilance requirements.Key...
-
Head of Regulatory Affairs
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Head of Regulatory AffairsEmporium is seeking a highly skilled and experienced Head of Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring compliance with relevant regulations and laws, as well as developing and implementing effective regulatory strategies.Key Responsibilities:Develop and...