Associate Director, Regulatory Affairs

2 weeks ago

Midrand, South Africa MSD Full time

**Major Activities Major activities include, but are not limited to**:

- Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency and Advisory Committee members, with continuous interface with RAI, EEMEA regional liaisons.

**Maintenance of licenses for assigned products**:

- 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 communicates 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 the company and local standards and 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 AMS Blue to generate mockup 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.

**Labeling and artwork**:

- Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
- Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

**Cross-functional activities**:

- Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials.
- Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
- Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
- 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.
- Participates, provides active input and lead if the case the local Medical Governance.

**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 the company's interests.
- Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the Global & EEMEA Regulatory Policy lead.
- Participates in internal registration managers' meetings at sub-regional and regional level and EEMEA regulatory workgroups on selected issues.
- For new regulations, identifies and tracks changes/trends that might impact the company's business.
- Participates in task forces of Pharmaceutical Industry/Agency.

**Manage direct report, as applicable**:

- Sets up priorities, organizes, oversees and monitors direct report's activities, towards division's and country's objectives achievement in compliance with policies and standards.
- Ensures that direct reports are trained for their proper use of internal regulatory systems.
- Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory.
- Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas of the company.
- Fosters a positive team spirit of the staff.

**Qualifications and Experience Required**:

- ** Minimum BPharm or other life science or equivalent.**
- **A minimum of** 5-10** years' Pharmaceutical Industry/Medical or Biotechnology experience.**

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition I

  • Regulatory Affairs Associate

    2 weeks ago

    Midrand, South Africa Alcon Full time

    At Alcon, we are driven by the meaningful work we do to help our patients see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Regulatory Affairs Manager

    2 weeks ago

    Midrand, South Africa Cipla Full time

    **Division**: Regulatory Affairs **Department**: Regulatory Affairs **Employment Type**: Permanent **Job Purpose**: - Manages submissions to different Health Authorities within the Regulatory Affairs function by ensuring the targets are reached as committed during each financial year. - Manages registrations and engagement with the different Health...

  • Regulatory Affairs Graduate

    2 weeks ago

    Midrand, South Africa MSD Full time

    Let us help you make a difference! We are calling on the best and brightest talent to join our dynamic and innovative organization! Future Leaders will be selected for a two year graduate program and placed in different divisions depending on your choice of career. In the divisions you will have access to some of the best minds in the business, acquiring...

  • Regulatory Affairs Manager

    5 days ago

    Midrand, Gauteng, South Africa 卡湯晩 Full time

    Job SummaryWe are looking for a Regulatory Affairs Manager to join our team. The successful candidate will be responsible for ensuring that all regulatory requirements are met, and that our products comply with relevant laws and regulations.The ideal candidate will have excellent knowledge of regulatory requirements, with the ability to interpret and apply...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (OTC) POS24328Area: MidrandSalary R900 R1mQualificationsBachelors 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...

  • Regulatory Affairs Manager

    1 day ago

    Midrand, Gauteng, South Africa Jordan HR Full time

    As a Senior Regulatory Affairs Pharmacist at Jordan HR, you will play a critical role in ensuring compliance with relevant regulations and developing effective regulatory strategies. Your expertise will be essential in managing a portfolio of product outputs and collaborating with internal departments and external partners.About the PositionDevelop and...

  • Regulatory Affairs Specialist

    1 day ago

    Midrand, Gauteng, South Africa Jordan HR Full time

    At Jordan HR, we are seeking a highly skilled Senior Regulatory Affairs Pharmacist to support our regulatory team in providing exceptional regulatory services. This role involves managing a portfolio of product outputs and ensuring compliance with relevant regulations.Key ResponsibilitiesCollaborate with the regulatory team to provide superior regulatory...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist OTC POS24203Based: MidrandSalary: R750KQualifications/experienceBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council3 to 5 years experience in Regulatory Affairs, preferably in human medicinesDemonstrable experience across the product development, commercialization and...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist OTC POS24203Based: MidrandSalary: R750KQualifications/experienceBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council3 to 5 years experience in Regulatory Affairs, preferably in human medicinesDemonstrable experience across the product development, commercialization and...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (OTC) POS24326Area: MidrandSalary R900 R1mQualificationsBachelors 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...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Midrand, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (OTC) POS24328 Area : Midrand Salary R900 R1m Qualifications Bachelors 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...

  • Regulatory Affairs Pharma

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD) - POS24325Area : MidrandSalary R950 R1mQualificationsBachelors 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...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (CAM) POS2432Area: MidrandSalary R900 R1mDivision: Complimentary Medicine QualificationsBachelors 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...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (CAM) POS2432Area: MidrandSalary R900 R1mDivision: Complimentary Medicine QualificationsBachelors 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...

  • Oncology Medical Affairs Lead

    1 week ago

    Midrand, South Africa MSD Full time

    The Associate Medical Director is responsible for the team’s scientific activities and performance. The individual will lead the Oncology Medical team assigned to given therapeutic areas. The Associate Medical Director is responsible for input and insight based on his/her team interaction with their SLs and other stakeholders’ engagements into the...

  • Regulatory Affairs Specialist

    2 days ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    As a Regulatory Affairs Pharmacist with Emporium Human Capital, you will play a pivotal role in ensuring the compliance of pharmaceutical products in South Africa and other territories. Your primary responsibility will be to manage work streams for- and report on the assigned portfolio of products, including internal product queries from relevant departments...

  • Regulatory Affairs Specialist

    1 day ago

    Midrand, Gauteng, South Africa The Recruitment Council Full time

    The Recruitment Council is seeking a highly skilled Regulatory Affairs Specialist to join our team in Midrand. The successful candidate will play a critical role in overseeing compliance with financial regulations and industry guidelines.Key ResponsibilitiesMonitor and summarize regulatory developments for PSG divisions.Collect and submit comments on...

  • Regulatory Affairs Assistant

    2 weeks ago

    Midrand, South Africa ITrain Full time

    The YES 4 Youth Programme is an exciting 12-month career development program crafted for graduates with a real passion for a future in Regulatory/Healthcare. **Requirements of the role** - Completed Bachelor’s degree in a medical area. - We are seeking a motivated and detail-oriented Regulatory Affairs Intern to join our team for 12 months. This...

  • Manager: Regulatory Affairs

    3 weeks ago

    Midrand, Gauteng, South Africa The Recruitment Council Full time

    Job DescriptionThe Strategic Regulatory Affairs Manager plays a critical role by overseeing compliance with financial regulations and industry guidelines. Reporting to the Head of Public Policy and Regulatory, this senior position is tasked with ensuring the organization''s understanding and adherence to evolving regulatory standards. The manager will...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Midrand, South Africa Cipla Full time

    **Department**: Regulatory Affairs **Job Purpose**: **Accountabilities**: - CDT/New dossier submissions and approvals - Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines. - Dossier Life Cycle Management - Perform the dossier life cycle management activities by supporting the post...