Regulatory Affairs Manager

Regulatory Affairs Manager

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Head of Regulatory Affairs Middle East

Ubicazione:

Europe/Middle East/Africa, United Arab Emirates, Dubai, Dubai

Luogo di lavoro:

Ibrido

Cosa farai

Kenvue is currently recruiting for:

Regulatory Affairs Manager

This position reports into the Regulatory Affairs Director – RAMET and is based in Dubai, UAE

What 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®, 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: Regulatory Affairs Director – RAMET

Location: Dubai, UAE

Travel %: 10%

What you will do

Manages a brand/s or segment of significant brand with some support from line manager. Drives market/consumer research and competitive intelligence gathering initiatives and uses insights to develop short to mid-term plans for key brands. With some support from line manager, plans, co-ordinates and drives business planning, brand management, brand planning, market research, new product development and roll out and business performance tracking.  Drives the development and execution of brand plans against key objectives with a view to delivering against the financial and market share commitments. Leads within scope of role.

Job purpose:

The Regulatory Affairs Manager is an expert with an in-depth understanding of the regulatory environment within GCC countries as well as requirements and strategies 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,
• 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 GCC countries and/or brand area of responsibility
• Maintains compliance for all products with local regulations and quality system requirements
• 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 Commercial/Marketing teams within a cluster.

The roles and responsibilities include:

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/labeling, 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 local 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

Qualification and Essential knowledge and skills:

• Relevant bachelor’s degree or higher, in Pharmacuitical Sciences or relevant fields
• 8+yrs related regulatory experience
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices in GCC countries.
• 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 GCC countries.
• Leadership and coaching skills with proven experience of people development
• Proficiency in English and Arabic
• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within GCC countries.
• Strong personal and people leadership, able to coach and develop emerging talent
• Broad knowledge of consumer healthcare environment and product development

Core Competencies

• 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 Regulatory Affairs 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

What’s in it for you

• Competitive Benefit Package*       
• Learning & Development Opportunities        
• Employee Resource Groups         
• This list could vary based on location/region

       

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

       

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.

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