Regulatory Affairs Manager

2 weeks ago

Cape Town, South Africa Kenvue Full time

**Regulatory Affairs Manager**-2307006564W

Description

Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for:
**Regulatory Affairs Manager**

This position reports into Head of Regulatory and Medical Affairs, SSA Cluster and is based at Cape Town, South Africa

**Who we are**

At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

**What will you do**

Manages and provides regulatory support of individual product portfolios for Regulatory & Medical Affairs Sub-Sahara Africa cluster, including registration, pre-approval and post-approval activities, in line with the strategic objectives of the Johnson & Johnson Consumer Sub-Sahara Africa business and the EMEA Regulatory & Medical Affairs organisation.
- Ensures that all aspects of Johnson & Johnson (JnJ) remain in compliance with the various laws and regulations pertaining to the registration procedures in the markets of the Sub-Sahara Africa cluster.

Key Responsibilities***
- **Regulatory Strategy and business orientation**
- o Understands and interprets the regulatory environment in terms of applicability to the Kenvue/JnJ business
- o Anticipates barriers and develops alternative plans of action
- o Provide regulatory strategy and advice and ensure that appropriate due diligence is carried out for product acquisitions and distributor agreements with third parties
- o Provides consultative support to product marketing teams on business decisions with regulatory implications
- o Effectively develop Regulatory team to a best in class by providing leadership, coaching, building

o capabilities and identifying development opportunities for key talent.
- **Manages Product Portfolio**

Effectively manages a portfolio of assigned products in all aspects of Regulatory Affairs and ensures timely completion of activities in line with departmental, regional and business goals.
- o Registration of New Products/Claims

o Conduct document review in order to ensure regulatory quality and scientific integrity of documents submitted to regulatory authorities

o Monitor follow up and report on progress of regulatory submissions
- **Marketed Products**

Ensure regulatory compliance of marketed products by updating and renewing product licenses as required, including:
o Variations

o Renewal /extension of marketing authorisations o Updating of product dossiers

o Maintenance of supportive databases

o Pharmaceutical and/or Expert reports

o Regular contact with regulatory agency staff to facilitate expedient review and approval of regulatory submissions
- **Product Labelling**

o Develops labelling in conjunction with medical affairs for registration packages

o Updates and maintains product labelling in line with corporate and country regulatory agency requirements
- **Advertising and Promotional Material Approval**

o Reviews and approves advertising and promotional material ensuring compliance with country regulatory requirements, marketing guidelines and corporate standards

o Ensures that agency approval is obtained for advertising material prior to commencement of advertising campaigns in the appropriate countries
- **Communication and influencing**
- o Interacts and participates in negotiation discussions on regulatory matters with Regulatory Authorities, as appropriate
- o Develops and maintains relationships and contacts with key personnel at the Regulatory agencies, key opinion leaders, academics and peers within the industry

o Actively participates in trade associations to positively influence the regulatory environment

o Represents the company/department to internal and external clients
- o Ensures that business is conducted tactfully and professionally and that a favourable company image is created and maintained
- o Develops a network within the JnJ organization, and effectively interacts at multiple organization levels and with diverse, multi-disciplinary individuals to encourage information flow and dissemination
- o Maintains contact and builds relationships with company subsidiaries and third-party agents in Export Territories.
- o Develops, maintains and demonstrates in-depth knowledge of local and major international laws and regulations pertaining to regulatory affairs, and their implications to Kenvue/JnJ. Brings to management attention in a timely manner, any proposed changes in national regulatory laws and procedures where the company has an interest.
- o Provide

  • Regulatory Affairs Pharmacist

    2 days ago

    Cape Town, South Africa Pollock and Associates Full time

    Regulatory Affairs Pharmacist FMCG / Food & Bev /Agri ~ Pharmaceuticals Cape Town - Western Cape - South Africa You will be required to ensure continued compliance with national and international regulations/legislations pertaining to cosmetics and the company supplements range, including worldwide registration of company products. B. Pharm degree is...

  • Regulatory Affairs Pharmacist

    5 days ago

    Cape Town, South Africa Recruitment Matters Africa Full time

    / legislations pertaining to cosmetics and supplements range, including worldwide registration of products. **Responsibilities**: - Investigates and interprets the regulatory and legislative needs globally and summaries the requirements as per business needs. - Manages and is responsible for the registration of products and supplements globally by...

  • Head of Regulatory

    1 week ago

    Cape Town, South Africa Kenvue Full time

    **Head of Regulatory & Medical Affairs SSA**-2206088521W **Description** **Johnson & Johnson Consumer** business is recruiting for a **Head of Regulatory Operations, Scientific Affairs and External Engagement, SSA** **Cluster**, located in **Cape Town, South Africa.** **Johnson & Johnson New Planned Consumer Health Company,** based in Skillman, N.J., is...

  • R&d Regulatory Affairs Associate Analyst

    4 days ago

    Cape Town, South Africa PepsiCo Full time

    **Responsibilities**- Regulatory Affairs Discipline Approver for ingredient Specifications.- Learn, understand and uphold the PepsiCo Global Ingredient Standard and Supplier Standard, and become proficient in the PepsiCo systems/IT Applications associated to spec writing.- Conduct gap analysis of legacy specifications against PepsiCo Global Ingredient...

  • Head of Medical Affairs

    7 days ago

    Cape Town, South Africa Guardian Recruiting Full time

    **_Job Requirements_** Directs all medical activities and scientific activities and ensures compliance with ethical and medical legal requirements, as well as manage the Medical Affairs Key point of contact for all external medical and scientific information Custodian of ethical marketing conduct for the Company Develop a medical and scientific strategy that...

  • Regulatory Assurance Lead

    1 week ago

    Cape Town, South Africa Teleperformance South Africa Full time

    **Regulatory Assurance Lead: role overview** The Regulatory Assurance Lead will take responsibility of the delivery of the annual monitoring plan by undertaking FCA related monitoring reviews and health checks across all financial services campaigns. Reporting to the UK Regulatory Compliance Manager, the role will lead the Regulatory Assurance Team in South...

  • Nonclinical Medical Writing Consultant

    1 week ago

    Cape Town, South Africa MMS Full time

    This role is a project-based consulting opportunity and will participate in the development, writing, and management of Nonclinical-related documents. **Roles and Responsibilities**: - Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB],...

  • Nonclinical Medical Writing Consultant

    5 days ago

    Cape Town, South Africa MMS Full time

    This role is a project-based consulting opportunity and will participate in the development, writing, and management of Nonclinical-related documents. **Roles and Responsibilities**: - Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB],...

  • Senior Project Manager-Regulatory Implementation

    Found in: Talent ZA 2A C2 - 2 weeks ago

    Cape Town, South Africa Datonomy Solutions Full time

    We are looking for a Senior Project Manager to join our team in Cape Town- 3 days onsite.This role is responsible for managing one or more projects within the constraints of scope, quality, time & cost, within the project governance framework.Delivers the required outcomes for each project, phase or stage.Ensures that quality is achieved as planned.Deliver...

  • Associate Manager, Clinical Trials Regulatory Management- Home-based, Europe

    Found in: Talent ZA C2 - 2 weeks ago

    Cape Town, South Africa IQVIA Full time

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...

  • Csi Manager

    2 days ago

    Cape Town, South Africa Siyakha Consulting Full time

    Job description We are currently hiring for a prominent global seafood company ranked among the top 20 in the industry. This black-owned organization holds a Level 1 B-BBEE contributor status and specializes in the comprehensive operations of seafood acquisition, processing, marketing, and distribution. **Role Overview**: As a CSI Manager, you will play a...

  • Senior Project Manager-Regulatory Implementation

    Found in: Whatjobs ZA C2 - 4 days ago

    City of Cape Town, South Africa Datonomy Solutions Full time

    We are looking for a Senior Project Manager to join our team in Cape Town - 3 days onsite . This role is responsible for managing one or more projects within the constraints of scope, quality, time & cost, within the project governance framework. Delivers the required outcomes for each project, phase or stage. Ensures that quality is achieved as planned....

  • Senior Project Manager-Regulatory Implementation

    Found in: Adzuna ZA B C2 - 1 week ago

    City of Cape Town, South Africa Adzuna ZA B C2 Full time

    We are looking for a Senior Project Manager to join our team in Cape Town- 3 days onsite.This role is responsible for managing one or more projects within the constraints of scope, quality, time & cost, within the project governance framework.Delivers the required outcomes for each project, phase or stage.Ensures that quality is achieved as planned.Deliver...

  • Senior Project Manager

    Found in: Adzuna ZA B C2 - 1 week ago

    Cape Town, South Africa Adzuna ZA B C2 Full time

    Responsibilities This role is responsible for managing one or more projects within the constraints of scope, quality, time and cost, within the project governance framework. The incumbent is individually accountable for achieving results through the efforts or others. Responsible for managing one or more projects within the constraints of scope, quality,...

  • Senior Project Manager

    Found in: Talent ZA 2A C2 - 2 weeks ago

    Cape Town, South Africa PM Connection Full time

    Responsibilities This role is responsible for managing one or more projects within the constraints of scope, quality, time and cost, within the project governance framework. The incumbent is individually accountable for achieving results through the efforts or others. Responsible for managing one or more projects within the constraints of scope, quality,...

  • Senior Project Manager

    Found in: Talent ZA C2 - 2 weeks ago

    Cape Town, South Africa Project Management Connection Full time

    Responsibilities This role is responsible for managing one or more projects within the constraints of scope, quality, time and cost, within the project governance framework. The incumbent is individually accountable for achieving results through the efforts or others. Responsible for managing one or more projects within the constraints of scope, quality,...

  • Client Relationship Manager

    Found in: Whatjobs ZA C2 - 4 days ago

    Cape Town, South Africa CF Consulting Full time

    OVERALL PURPOSE The role requires one to manage a book of Ultra High Nett-Worth clients and be the primary contact for client families and co-ordinate their overall affairs and engagement with the Company. It will involve close and regular interaction with clients and third parties of the Group as well as with internal departments and business units.  ...

  • Client Relationship Manager

    Found in: Talent ZA 2A C2 - 2 weeks ago

    Cape Town, South Africa CF Consulting Full time

    OVERALL PURPOSEThe role requires one to manage a book of Ultra High Nett-Worth clients and be the primary contact for client families and co-ordinate their overall affairs and engagement with the Company. It will involve close and regular interaction with clients and third parties of the Group as well as with internal departments and business...

  • Client Relationship Manager

    Found in: Talent ZA C2 - 2 weeks ago

    Cape Town, South Africa CF Consulting Full time

    OVERALL PURPOSEThe role requires one to manage a book of Ultra High Nett-Worth clients and be the primary contact for client families and co-ordinate their overall affairs and engagement with the Company. It will involve close and regular interaction with clients and third parties of the Group as well as with internal departments and business...

  • Supply Chain Management Practitioner: Logistics Contract and Performance Management, Ref No. CAS 22/2024

    Found in: Talent ZA C2 - 5 days ago

    Cape Town, South Africa Western Cape Government Full time

    The Department of Cultural Affairs and Sport, Western Cape Government has an opportunity for a suitably qualified and competent individual to provide a contract administration service in respect of supply chain management.