Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Senior Manager, Regulatory Affairs

Locatie:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Werklocatie:

Hybride

Wat je gaat doen

The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Skin Health & Beauty / Essential Health franchise.

• Evaluates and coordinates the regulatory deliverables for cosmetic &/or medical devices, within their geographical and/or brand area of responsibility

• Develops effective partnerships with R&D, Franchise (Marketing) and local regulatory colleagues. 

• Assists in the preparation of technical documentation for the registration and maintenance of products throughout their whole lifecycle

• Represents the Regulatory Affairs function as appropriate within the Skin Health & Beauty / Essential Health Franchise.

 

The Roles & Responsibilities include:

Regulatory Strategy

• Works with local and regional regulatory colleagues to develop global and/or regional regulatory

• Organizes materials from preclinical and clinical studies for review and assists in the review process.

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

• Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings.

• Tracks the status of applications under regulatory review and provides updates to the regulatory team

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

Regulatory Compliance

• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.

• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.

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

• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.

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

• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives

• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.

Regulatory Advocacy

·         Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintains information resources.

·         Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant). 

 

Specific requirements

• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.

• Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.

Other features of the job

 

• Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.

• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.

Back up activities

 

Represent the Senior Manager Skin Health & Beauty / Essential Health as delegate on request

Job Requirements

Essential knowledge and skills:

 

• Relevant Bachelor's Degree or higher 

• Expertise across a broad spectrum of Regulatory classifications including Cosmetics & Commodities

• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory

• undefined

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

• Proficiency in English

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 and 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 partnership

 

What’s in it for you?

• Competitive Benefit Package

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

• Extensive 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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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