VP Regulatory Affairs EMEA

VP Regulatory Affairs EMEA

What we do

At 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® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are 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 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. For more information, click here.

Role reports to:

Interim VP, R&D, EMEA

Location:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Work Location:

Hybrid

What you will do

The Vice President EMEA Regulatory Affairs role is a significant leadership role within Kenvue.  The incumbent supports all brands and Regulatory classifications (Drugs, Cosmetics, Medical Devices, combination products, Dietary Supplements). 

This role provides leadership for the largest and most complex region in the organization. Daily interactions with the regional lead team, EMEA R&D Leadership team, Board members, members of the Extended Global Regulatory Leadership Team and overall R&D Extended Leadership Team are required.  Importantly, the VP EMEA will play a lead role in cross functional meetings to drive the innovation agenda and will represent the function on the EMEA Policy Council and will lead regulatory discussions at Quality Review Board meetings. 

The incumbent will serve as the lead for one or more teams/committees within the global regulatory affairs organization such as the extended global regulatory leadership team.

The VP will work with the Global Head of Regulatory Affairs, the EMEA Regulatory Leadership Team and cross-functional partners (Commercial, R&D, Legal, Government Affairs and Policy, Communications) to anticipate, shape and respond to the wide range of issues and proposals that affect individual ingredients and classes of regulated products.  Examples include access to medicines and the overall framework for regulating products.  The incumbent will ensure appropriate and timely input to proposed Guidelines, regulations and laws and will strive to ensure Kenvue plays a leadership role in important trade associations (AESGP, Cosmetics Europe), ensuring company messages and priorities are accounted for. The incumbent must be comfortable and effective in the role of Company spokesperson at trade association meetings, public hearings and Scientific Advice Meetings as well as with media interactions, scientific meetings, and in interactions with other government agencies and staff. 

The position reports directly to the Global Head Regulatory Affairs. They collaborate with local and regional business and R&D leaders, local market managing directors, industry thought leaders, and key opinion leaders, and oversee regulatory negotiations with Health Authorities, government stakeholder, and NGOs.  

The incumbent ensures consistency of regulatory practices, procedures and standards for JJCI products, operations and businesses throughout the region as well as talent development and implementation of the Global Regulatory Affairs Strategic Plan.

The Vice President Regulatory Affairs provides the necessary leadership to enable strong regulatory strategies, impact assessments, and risk management plans that drive timely regulatory approvals, ensure continued access to marketed products, and that help drive achievement of business goals.  The company operates in a highly regulated business environment. The incumbent is responsible for ensuring all meetings and interactions with Health Authorities throughout the region take into account Kenvue-wide objectives and that meeting objectives are met and the strong reputation of the Company is maintained.  The incumbent will have a strong track record of building organizations that effectively interact with regulators even on the most challenging subjects.  

The VP leads development of key technical messages and strategies surrounding complex and politically-charged topics.  Recognizes the full range of implications (Legal, Communications etc) and partners cross-functionally to ensure regulatory plans reflect that understanding.

Responsibilities:

• The VP Regulatory Affairs EMEA will manage 8-10+ Direct Reports and more than 100 staff members overall and oversee a budget of approximately $20M.

• Act as the site lead for the UK R&D Operations Center, and provides critical leadership for the portfolio led out of the R&D innovation center in Helsingborg Sweden where global smoking cessation, cough/cold and digestive health innovation is led.

• Responsible for managing timelines to ensure development and delivery of dossiers and coordinates post-submission regulatory negotiations to ensure product approvals per Company commitments, and ensures timely execution of the activities to support product launch and post-launch lifecycle management. 

• Drive collaboration with R&D and business colleagues to develop robust yet innovative claims supported with sound science.  The incumbent serves as senior regulatory counsel in determinations of regulatory risk for products and claims.  This includes developing and maintaining compliance and audit readiness, developing and managing credible relationships with regulatory agencies across the region. 

• Be a key driver of the Kenvue strategy and culture.  Building and reinforcing a team of engaged employees who embrace reality based optimism as they develop regulatory options and plans, and who build quality into all aspects of their work is a critical part of this leadership role. The role drives understanding and commitment to goals and objectives and inspires employees to be part of the overall Kenvue growth strategy. 

• Be a champion of change management both as a role model and an educator of the organization on this critically important capability. The incumbent will lead projects and initiatives that help drive the success of Kenvue independent of functional role.  

• As a member of the global leadership team the Vice President will identify opportunities to strengthen the efficiency and effectiveness of the regulatory organization.  They will play a leadership role in the development and execution of plans to increase regional and global skill sets, regulatory capabilities and people leadership skills to build a roster of future regulatory leaders.

Essential Knowledge & Skills:

• A minimum of 15 years of experience in Regulatory Affairs.  

• A Ph.D. is preferred; candidates with a Master’s or Bachelor’s Degree will be considered. 

• Experience with INDs, NDAs/sNDAs, monograph products and knowledge of the Rx to OTC switch process and ANDAs is essential.  Experience with Devices, Dietary Supplements and Cosmetics is desirable, although not required.  

• Previous experience partnering with or managing teams or projects outside of North America is strongly preferred.
• A strong track record of achieving approvals and driving data and fact-based discussions is critical, as is experience working with industry counterparts and trade association committees and task groups.
• The ideal candidate will be a proven people and technical leader, including having managed and led large teams of people in a project team/matrixed organization as well as experience successfully managing across a diverse range of commercial and technical functions, product categories and geographies. 

• Demonstrated cross-functional collaboration and leadership with other technical functions such as Product Development, Quality Assurance and senior business leaders is essential.

• Demonstrated success in leading change-management initiatives is required.

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