Head of Regulatory Affairs South Africa

Head of Regulatory Affairs South Africa

This position reports into Director: Regulatory Affairs and is based at Cape Town, South Africa.

What you will do

The Senior Manager of Regulatory Affairs (Market) is a country expert with an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

• Leads the Regulatory Affairs team, ensuring the success of new product registrations, line extensions and new indications and claims in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requirements.

• Create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve affiliate regulatory objectives

• Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility

• Facilitates and cultivates external relationships, representing Kenvue with the relevant regulatory agencies and industry & professional associations as required

• Represents the Regulatory Affairs function as appropriate in Cluster functional and business Leadership teams.

• The role requires close cooperation with General Director/Board members/ Commercial/Marketing teams within a cluster 

Key Responsibilities

Regulatory Strategy

• Provides regulatory input and technical guidance on local regulatory requirements to product development teams

• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements.

• Provides regulatory assessment and guidance for proposed product claims/labelling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product claims.

• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.

• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.

• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.

Regulatory Compliance

• Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally

• Ensures that all products comply with local regulatory and quality system requirements.

• Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions

• Reviews and approves promotional materials for all local Kenvue products and assists in claim support along with the Cluster.

• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.

• Ensures that the enterprise Regulatory systems are accurate and fully maintained

• Ensure any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally

• Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives

• Manages and supports internal and external audits and inspections in collaboration with quality function

What we are looking for

Required Qualifications

• Relevant bachelor’s degree or higher 

• 8+yrs related regulatory experience 

• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices

• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.

• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance

• Leadership and coaching skills with proven experience of people development

• Proficiency in English

For Qualified person (preferred but not manadatory requirement):

• Be member of Pharmacist association

• Be designated QP by the Health Authorities

• Knowledge of GMP and European legislation (Eudralex, Directive, ISO) for pharmaceutical products

• Knowledge of production, Quality Assurance, Quality Control, validation.

• At least 2 years of experience as QP deputy

Where required, the Senior Manager Regulatory Affairs may have additional responsibilities including but not limited to:

• Qualified Person

• Responsible Person

• Management & oversight of GMP Inspections and/or

• Compilation & submission of Pricing Applications &/or product reimbursement requests to the relevant national Regulatory authorities

Where Qualified Person:

• Be the representative of the company for the Health Authorities, as responsible Qualified Person.

• Approve and be responsible for all technical documentation related with registration and Marketing Company authorization.

• Ensure compliance with the authorized specifications of each product.

• Ensure that GMP’s are applied, even if these operations are outsourced to an external manufacturer.

• Approve all Business Quality procedures of the marketing Company.

Essential knowledge and skills

• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility

• Excellent personal and people leadership, able to coach and develop emerging talent

• Broad knowledge of consumer healthcare environment and product development

• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.

• Strong interpersonal skills; able to build effective personal networks internally and externally.

• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.

• Strong organizational and time management skills with an ability to work under pressure.

• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic, results-driven environment.

• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums. 

• Able to work effectively in a multi-cultural, highly matrixed organization

• Experience in cultivating and leveraging strategic networks and partnerships

• Proficiency in English

What’s in it for you

• Competitive Benefit Package    

• Learning & Development Opportunities        

• Employee Resource Groups         

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.