Senior Regulatory Affairs Specialist

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Senior Regulatory Affairs Specialist (2407028556W) This position reports into the Head of Regulatory Operations and is based at Cape Town, South Africa. Who We Are 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. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. What You Will Do The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways, compliance activities, and the potential impact of these on business objectives.

1. Ensures the success of new product registrations, line extensions, and new indications and claims in alignment with the business plan.
2. 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.
3. Maintains compliance for all products with local regulations and quality system requirements.

Key Responsibilities The Roles & Responsibilities include:

1. Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
2. Assesses the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements.
3. Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with local regulatory requirements.
4. Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
5. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
6. Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments.
7. Ensures that all products comply with local regulatory and quality system requirements.
8. Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs, and working instructions.
9. Reviews and approves promotional materials for assigned local Kenvue products.
10. Supports internal and external audits and inspections in collaboration with the quality function.

Specific Requirements

• Relevant Bachelor's Degree (B.Pharm) or higher (M.Pharm, Msc. Pharm etc.)
• 6+ years 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.
• 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.

What We Are Looking For

• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation.
• Strong personal and people leadership, able to coach and develop emerging talent.
• Excellent communication skills, with the ability to articulate and express concepts clearly.
• Strong interpersonal skills; able to build effective personal networks.
• Highly collaborative with a strong sense of ownership.
• Strong organizational and time management skills.

What’s In It For You · Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!· Learning & Development Opportunities 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.

Primary Location

Europe/Middle East/Africa-South Africa-Western Cape-Cape Town #J-18808-Ljbffr