OverviewKenvue High Wycombe, England, United Kingdom

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Regulatory Affairs Consultant

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Kenvue

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RoleRegulatory Affairs Consultant

Location:

High Wycombe, UK

Duration:

6 months

Hours:

40 hours

The Regulatory Affairs Consultant EMEA (Self Care) 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 Self Care franchise.

Evaluates and coordinates the regulatory deliverables for medicines and food supplements, within their geographical and/or brand area of responsibility

Develop effective partnerships with RandD, Franchise (Marketing) and local regulatory colleagues to deliver projects

Assists in the preparation of dossiers and submission packages for the registration and maintenance of products throughout their whole lifecycle

Represents the Regulatory Affairs function as appropriate within the cross functional project teams

Support regulatory activities for European procedures as appropriate

Responsible for meeting compliance requirements within teams such as SOP training, audits etc.

Partner with other critical functions to execute plans to address crises and other sensitive issues.

Uses effective communication and influencing skills to drive projects

Roles and ResponsibilitiesRegulatory 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 dossiers to support local review processes.

Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.

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.

Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties.

Regulatory Compliance

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

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

Ensures that the Regulatory systems are accurate and fully maintained

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

Support internal and external audits and inspections in collaboration with quality function

Specific requirements

Partners with the business to deliver regulatory outcomes to enable committed business plans within the 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.

Applies organizational understanding and awareness in decision making.

Use effective communication and employ influencing skills to continue to grow key relationships with internal/external contacts.

Essential knowledge and skills

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

Applies organizational understanding and awareness in decision making.

Use effective communication and employ influencing skills to continue to grow key relationships with internal/external contacts.

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 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.

Proficiency in English

This role offers a very competitive hourly rate. This contract will run for a minimum of 6 months.

Diversity, Equity and 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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance and Research

Industries

Personal Care Product Manufacturing

Food and Beverage Manufacturing

Pharmaceutical Manufacturing

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