Regulatory Affairs Specialist

7 months ago

Midrand, South Africa MSD Full time

Our 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 world.

**Position Overview - Basic Functions & Responsibility (may not be limited to)**:

- For assigned products ensures high quality labelling translation and artwork management.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval in cooperation with other internal stakeholders.
- For assigned products and tasks, stays updated on relevant local regulations and guidelines.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts.

**Major Activities (may not be limited to)**:
**Maintenance of licenses for assigned products.**
- Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

**Compliance**
- For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
- Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
- Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

**Labelling and Artwork**
- Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
- The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.

**Cross-functional activities, as assigned**.**
- Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
- Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
- Adequately supports other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.

**Regulatory policy & environment**
- Keeps abreast of local and international laws.
- Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with our company's interests.
- Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
- Participates in internal regulatory workgroups.

**LOCAL REQUIREMENTS, as applicable**

**Quality**
- Ensures handling of customer complaints and support product recalls activities according to our standards and local procedure. Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP), our Manufacturing Division, Customer Service and/or PhV, QP at wholesaler/distributor/importer level and/or Management (Crisis) team.
- Under supervision by QRP/QCP performs assigned tasks regarding product quality and safety according to local requirements.

**Experience and Qualifications Required**:

- ** Minimum BPharm or other life science or equivalent.**
- **A minimum of 2 years' experience in the regulatory environment/department in Sub-Sahara Africa (e.g Ethiopia. Kenya, Namibia, Tanzania, Uganda etc.).**
- A sound appreciation of the interactions and relationships of the dept with other groups internally and externally is expected.
- Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
-

  • Regulatory Affairs Specialist

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Emporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team in Midrand. The ideal candidate will have a Bachelor's degree in Pharmacy and a strong background in regulatory affairs, preferably in human medicines.The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and...

  • Regulatory Affairs Manager

    1 week 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 time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital. In this role, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Assist with internal product queries from relevant departmentsAssist with...

  • Regulatory Affairs Pharmacist Specialist

    7 days ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job 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 time

    Job 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 Specialist

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Senior Regulatory Affairs SpecialistCompany Overview:Emporium Human Capital is a leading provider of human resources solutions, dedicated to helping businesses find the right talent for their needs.**Job Summary:** We are seeking an experienced Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Emporium Human Capital. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for human medicines and medical devices.Key ResponsibilitiesManage work streams for internal and external...

  • Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Full time

    Regulatory 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

    2 months ago

    Midrand, Gauteng, South Africa The Recruitment Council Full time

    At The Recruitment Council, we are seeking a skilled Regulatory Affairs Specialist to play a pivotal role in ensuring our organization's compliance with financial regulations and industry guidelines. The successful candidate will oversee compliance with financial regulations and industry guidelines, collaborating closely with legal, compliance, and risk...

  • Associate Specialist, Regulatory Affairs

    6 months ago

    Midrand, South Africa MSD Full time

    **Basic Functions & Responsibility (may not be limited to)**: - Under supervision of the Country Lead/Senior Director/Director/Associate Director/Manager Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations,...

  • Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory 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...

  • Regulatory Affairs Specialist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job 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...

  • Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.About the Role:We are looking for a talented Regulatory Affairs Pharmacist to manage work streams for- and report on the assigned portfolio of products. This includes internal product queries from relevant departments and...

  • Regulatory Affairs Specialist for Human Medicines

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    At Emporium Human Capital, we are seeking an experienced Regulatory Affairs Specialist to join our team in Midrand. This exciting opportunity will see you working on a portfolio of products, managing work streams and reporting on assigned tasks.The ideal candidate will have a Bachelor's degree in Pharmacy or Diploma in Pharmacy, along with registration with...

  • Regulatory Affairs Specialist

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    **Job Title:** Regulatory Affairs Pharmacist**Location:** Midrand, South Africa**Estimated Salary:** R 945,000 per annum (based on industry standards)**Company Overview:We are Emporium Human Capital, a leading recruitment agency in South Africa.We specialize in finding top talent for various industries, including pharmaceuticals.**Job Description:Key...

  • Regulatory Affairs Specialist for Pharmaceutical Compliance

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job 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 Specialist

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital.

  • Regulatory Affairs Pharmacist Specialist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Full time

    Emporium Job Overview">We are seeking a seasoned Regulatory Affairs Specialist to join our team at Emporium, contributing to the development of high-quality pharmaceutical products. The successful candidate will be responsible for managing regulatory activities and ensuring compliance with relevant standards.">About the Role">This is an exciting opportunity...

  • Manager: Regulatory Affairs

    2 months ago

    Midrand, South Africa SET Recruitment Consultants Full time

    Manager: Regulatory AffairsMarket-related Salary PackageMidrand, GautengRole PurposeThe Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...

  • Manager: Regulatory Affairs

    2 months ago

    Midrand, South Africa Set Consulting Full time

    Manager: Regulatory AffairsMarket-related Salary PackageMidrand, GautengRole PurposeThe Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for company ensuring the group's understanding and adherence to relevant financial...