Skin Health Regulatory Affairs Director - EMEA

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Job title: Director Regulatory Affairs (Skin Care)

Reporting to: Vice President Regulatory Affairs EMEA

Functional group: EMEA Regulatory Affairs (R&D)

Location: Reading, United Kingdom

The Director of Regulatory Affairs leads the regulatory affairs deliverables for the Skin Care franchise ensuring the success of

new product registrations, line extensions and new indications in alignment with the business plan, while overseeing

compliance for all products with relevant regulations and quality system requirements.

• Management of the Skin Care Regulatory Affairs team & monitoring of associated regulatory spend

• Provides strategic vision & creates an environment of operational excellence through regulatory expertise by

managing and developing direct reports and collaborating with cross-functional teams to successfully achieve

local/regional regulatory objectives.

• Assesses links between global, societal, public health and economic trends; stakeholder concerns and regulatory

issues and requirements; and the implications for regulatory strategy.

• Develop and implement regulatory plans and strategies in alignment with agreed business plans and in compliance

with applicable global and/or regional regulatory requirements.

• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends

changes or refinements based on initial regulatory outcomes.

• 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 Skin Care and EMEA Regulatory Affairs Leadership teams

The Roles & Responsibilities include:

Regulatory Strategy

· Provides strategic input and technical guidance on global/regional regulatory requirements to product development

teams.

· Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.

· Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions

· Monitors implementation of regulatory strategies relative to product and clinical safety issues identified

· Provides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and non clinical

data, to ensure compliance with the local regulatory requirements and to optimise the proposed product

positioning.

· Leads key negotiations and interactions with regulatory authorities during all stages of the development and review

process

· Prepares cross functional teams for interactions with regulatory authorities including scientific advice meetings

· Adapts pre and post market strategy based on consideration of factors such as reimbursement, public health policies, state/provincial/regional restrictions and other legislative/regulatory requirements.

Regulatory Compliance

· Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches and advises internal stakeholders on a course of action. · Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products

· Negotiates with regulatory authorities on complex issues throughout the product lifecycle. · Ensure that all applicable Processes, SOPs and working instructions are adhered to.

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

· Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).

· Identify local process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives Regulatory Advocacy · Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.

· Drive new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products.

· Engages with stakeholder groups to help shape science based regulatory decision making as required

Requirements

· Relevant Bachelor's Degree or higher

· 10+yrs related regulatory experience

· Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices

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

· Proficiency in English

· Excellent personal and people leadership

· 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.

· 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.

· High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative solutions

· Able to work effectively in a multi-cultural, highly matrixed organisation

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