ExecutiveFull TimeEN
Kenvue is currently recruiting for a:
Head of Regulatory Affairs South AfricaWhat we do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.
Role reports to:
Interim VP, R&D, EMEALocation:
Europe/ Middle East/Africa, South Africa, West Cape, Cape TownWork Location:
HybridWhat you will do
Kenvue is currently recruiting for: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.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
