Regulatory Affairs Manager

1 week 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

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