Senior Manager Regulatory Affairs (m/f/d) UK & Ireland

Job title:

Senior Manager Regulatory Affairs (m/f/d) UK & Ireland

Company

Kenvue Brands LLC

Job description

DescriptionKenvue is currently recruiting for a:Senior Manager Regulatory Affairs (m/f/d)UK & IrelandThis position reports to Director Regulatory Affairs and is based at High Wycombe.Who we areAt 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® Brand Adhesive Bandages 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. With expertise and empathy, being a Kenvuer means having the power to impact the 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.What you will doThe Senior Manager of Regulatory Affairs (Market) is a country expert with an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.Key Responsibilities

• Leads the Regulatory Affairs team, ensuring the success of new product registrations, line extensions and new indications and claims in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requirements.

• 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 their geographical and/or brand area of responsibility

• 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

What we are looking forRequired Qualifications

• Relevant Bachelor’s Degree or higher

• 8 yrs related regulatory experience

• 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

• Proficiency in English

Desired Qualifications

• Be member of Pharmacist association

• Be designated QP by the Health Authorities

• Knowledge of GMP and European legislation (Eudralex, Directive, ISO) for pharmaceutical products

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

• At least 2 years of experience as QP deputy

What’s in it for you

• Competitive Total Rewards Package*

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

• Learning & Development Opportunities

• Employee Resource Groups

*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 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.

Expected salary

Location

High Wycombe, Buckinghamshire

Job date

Fri, 29 Nov 2024 23:53:29 GMT

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