Job Number: 17493

External Description:

Senior Regulatory Affairs Specialist (Skin Health & Beauty / Essential Health)

Location: High Wycombe

Working mode: Remote (1-2 times per month on-site)

Duration: 12 months

Hours: 32-37 hours per week

Pay rate range: Competitive hourly rate (PAYE and Umbrella options available)

 

Imagine your next project as Regulatory Affairs Specialist at Kenvue. 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.

roles and responsibilities

Regulatory Strategy 

• Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional technical files to support local review processes.
• 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. 
• 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 
• 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
• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives 
• Support internal and external audits and inspections in collaboration with quality function 

Regulatory Advocacy

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

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.

 

 

how to succeed

• 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 solutions throughout the product lifecycle.
• Solid understanding of regulatory/safety/quality requirements in the markets of relevance
• Proficiency in English 
• 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 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Kenvue is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Kenvue

At Kenvue, we realise 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 by 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

https://www.kenvue.com/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella  options are available. 

Diversity, Equity & Inclusion

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Job Number: KVUE2JP00000378

Community / Marketing Title: Senior Regulatory Affairs Specialist

Location_formattedLocationLong: London, Greater London GB