Description

recruiting for:

Senior Regulatory Affairs Specialist

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 with 22, 000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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 .

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 and compliance activities and the potential impact of these on business objectives.

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.

• 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.

• Maintains compliance for all products with local regulations and quality system requirements.

Key Responsibilities

The Roles & Responsibilities include:

Regulatory Strategy

• Works independently to provide 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, where relevant.

• Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product classification and 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 because 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 assigned local Kenvue products and assists in claim support.

• 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.

• Supports internal and external audits and inspections in collaboration with quality function.

Specific requirements

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

• 6 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 (where relevant):

• Be registered member of the South African Pharmacy Council

• Be designated Practising Pharmacist by the Health Authorities

• Knowledge of cGMP, ISO 13485, South African and Sub-Sahara Africa legislation for pharmaceutical, Cosmetics, Foodstuffs and Medical Devices

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

• At least 2 years of experience as QP deputy

Other features of the job

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

• Qualified Person

• Responsible Person

• Responsible Pharmacist

• 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.

• Release into the market each batch, once conformity with approved specifications is verified. Formalize this release through appropriate documents, which must be updated and available for auditors. OTC Batch release approvals and batch assignments approvals prepared and issued by Local Business Quality.

• Support the Health Authorities during inspections.

• Manage recall of products from the market, if needed, and communicate this decision to the Health Authorities.

• Verify the correct distribution of products.

What We Are Looking For

Required Qualifications

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

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

What's In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• 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.