Regulatory Affairs Manager

7 days ago


Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 72786

**Job Type**
- Permanent

**Job Title**
- Regulatory Affairs Manager

**Computer Skills**
- Ms Office

**Industry**
- Manufacture

**City**
- Johannesburg (Incl. Northern Suburbs)

**Province**
- Gauteng

**Reporting to Head: Regulatory Affairs**

**Job purpose**:

- Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.

**Key Job Outputs**
- Manage work streams for
- and report on the assigned group of portfolios
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal training and mentoring
- 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
- Ensure alignment of personal and company values**Inherent Requirements**

**Qualifications/Experience**
- Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
- Minimum of 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 deliver to quality, time and cost standards

**Core competencies**
- IT skills
- Leadership skills
- management of personnel resources
- Ability to prioritise 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

**What Qualification**
- Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

**Minimum Qualification**
- Bachelors

**Status**
- Available



  • Johannesburg, Gauteng, South Africa Dymaxa Recruitment Full time

    Job Opportunity: Regulatory Affairs ManagerDymaxa Recruitment is seeking a qualified Regulatory Affairs Manager to oversee compliance and regulatory activities for our client's organization.About the Job:This is an excellent opportunity for a seasoned professional to lead the development and implementation of regulatory strategies and procedures.Key...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72665 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...


  • Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Job Title: Regulatory Affairs ScientistLarge Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies:Key Responsibilities:Managing and coordinating the compilation and submission of new product applications.Managing and coordinating response to the regulatory authority.Maintain regulatory knowledge of the...


  • Johannesburg, South Africa MedicalCareers Full time

    A Pharmaceutical company has an opportunity for an experienced Regulatory Affairs pharmacist to join their team. Subordinates/ Direct Reports: Zero Main Purpose of Job To fulfil the position as regulatory affairs pharmacist for the company and any division within the group. Key Performance Areas (Core, essential responsibilities -outputs of the...


  • Johannesburg, Gauteng, South Africa Curiska Full time

    Curiska seeks a Regulatory Affairs Manager to support the team in ensuring compliance with regulatory requirements and internal policies. This role is ideal for individuals with a strong interest in compliance and a background in law or a related field.Job Summary:The Compliance Administrator will be responsible for providing support in various areas,...


  • Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Regulatory Affairs PharmacistLarge pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:Key Responsibilities:Ensure timeous initiation and management of the registration process for new product submissions.Ensure approval of registration applications of all medicines with the relevant authorities.Ensure...


  • Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs - Annually Cost To Company (Market related) Well established Pharmaceutical business seeking to appoint a Senior Regulatory Affairs Manager **Minimum Requirements**: - B Pharm or Related Scientific Degree - M Pharm an advantage but not a requirement - Regulatory Affairs Pharma Industry - 10+ years’ experience, of at least...


  • Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Manager (POS24191)Area: AerotonR1,5 1,7k paLead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 68543 **Job Type** - Permanent **Job Title** - Regulatory Affairs Systems Associate **Computer Skills** - MS Excel,Adobe Acrobat **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems,...


  • Johannesburg, Gauteng, South Africa Emporium Full time

    **Job Summary:**We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium.The successful candidate will be responsible for managing work streams and reporting on assigned portfolios of products, including internal and external product queries.Key Responsibilities:Establish regulatory priorities and allocate resources and...


  • Johannesburg, South Africa PPD Full time

    Regulatory Affairs Manager - South Africa We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the...


  • Johannesburg, South Africa iProcess Global Research Inc Full time

    JOB SUMMARY ESSENTIAL DUTIES Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72214 **Job Type** - Permanent **Job Title** - Junior Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - Entry Level position to Support the...


  • Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...

  • Director, Legal

    2 weeks ago


    Johannesburg, South Africa Onafriq Full time

    We are recruiting for a Director, Legal & Regulatory Affairs to join the Governance, Risk and Compliance team at Onafriq. This role will be responsible for managing the legal and regulatory affairs function and through their team will provide (a) legal advice and guidance across the Group, and (b) manage the Group’s regulatory agenda and engagements with...


  • Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Regulatory Affairs ScientistLarge Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies:Key Responsibilities:Managing and coordinating the compilation and submission of new product applications.Managing and coordinating response to the regulatory authority.Maintain regulatory knowledge of the various...


  • Johannesburg, South Africa PSM Personnel Full time

    Senior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications/experience - Bachelors Degree or Diploma in Pharmacy with the South African Pharmacy Council registration. - +-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end...


  • Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...


  • Johannesburg, Gauteng, South Africa Allan Gray Orbis Foundation Full time

    We are seeking a Regulatory Affairs Manager to join our team at the Allan Gray Orbis Foundation.Key ResponsibilitiesDevelop and implement regulatory compliance strategies to ensure the organization's governance, risk, and compliance (GRC) function is effective.Collaborate with stakeholders to identify, assess, and mitigate risks that may impact the...