Senior Director Regulatory Affairs (N EU & Skin/Essential Health Regional

Job Title: Senior Director Regulatory Affairs (N EU & Skin/Essential Health Regional)

Job Location: High Wycombe, UK

Job Location Type: Hybrid

Job Contract Type: Full-time

Job Seniority Level: Director

Job Description

The Senior Director of Regulatory Affairs is the group leader for the Northern European Cluster & Regional Skin & Essential Health franchise regulatory teams. They are responsible to ensure 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.

What Will You Do

• Management of the Northern Europe Cluster & Regional Skin & Essential Health Franchise Regulatory Affairs team & oversight of regulatory budget.
• 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.
• Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes.
• Accesses and interprets environmental scans and other socioeconomic, scientific and regulatory intelligence to better understand implications for regulatory strategy and product positioning, competition & opportunities/risks.
• Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products.
• Leads the regulatory team’s engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during preapproval/clinical phases.
• 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 Northern Europe Cluster, Skin & Essential Health Franchise and EMEA Regulatory Affairs Leadership teams.

The role will have approximately 5 Direct Reports and around 25 staff members overall.

Key Responsibilities

Regulatory Strategy

• Leads the regulatory team’s engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions.
• Critically assesses strategic input and technical guidance on global/regional regulatory requirements to product development teams.
• Provides recommendations to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight.
• Oversees implementation of regulatory strategies relative to product and clinical safety issues identified to ensure compliance and protect corporate interests.
• Approves 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

• Approves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical and manufacturing changes.
• Leads and represents the regulatory team in product associated events, recalls and product withdrawals.
• Leads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycle.
• Reviews and approves enforcement action/responses.
• Critically assesses the impact of changing regulations on preapproval and post-approval strategies and approaches and advises internal stakeholders on a course of action.
• Develops strategies for resolving complex issues with potential for significant regulatory impact.
• Ensure that all applicable Processes, SOPs and working instructions are adhered to.
• Support internal and external audits and inspections in collaboration with quality function.
• Approves the development and execution of new regulatory procedures and standard operating procedures (SOPs) and process improvement opportunities to drive operational efficiencies and compliance.

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.
• Acts as a thought leader to 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.

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• 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, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Job Function

Regulatory Affairs

Job Qualifications

What we are looking for

• Relevant Bachelor’s Degree or higher
• Proven and 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 knowledge of required regulatory frameworks including medicines, medical devices and cosmetic regulation as a minimum
• Excellent personal and people leadership
• Broad knowledge of consumer healthcare environment and product development
• 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.
• High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative solutions.
• Builds and sustains partnership across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Leads thorough analysis of situations with appropriate attention to details and the big picture including consideration of impact and risk.
• Wins support and buy-in from sponsors, partners and stakeholders by effectively satisfying stakeholder interests and concerns while advocating a clear direction forward; and coaches others to do the same.
• Models, encourages and creates the conditions for an inclusive and respectful work environment. Acts as a catalyst and change agent for creating an inclusive and respectful work environment.
• Able to work effectively in a multi-cultural, highly matrixed organisation.

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