Regulatory Affairs Manager

3 days ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

About the Role

The Senior Manager, Regulatory Affairs, CMC will lead a team responsible for developing CMC/technical regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.

Key Responsibilities

  • Lead a Regulatory Affairs team to ensure the success of new product registrations, line extensions, and new indications and claims with supportive technical justification/documentation in alignment with the business plan.
  • Create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives.
  • Manage global and/or regional regulatory deliverables for drugs, dietary supplements, and medical devices as relevant, within their brand area and geographic responsibility.
  • Develop strong partnerships with Regulatory Affairs Franchise, R&D, Franchise (Marketing), and local business representatives.
  • Facilitate and cultivate external relationships, representing Kenvue with the relevant regulatory agencies and industry and professional associations as required.
  • Represent the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional, and business Leadership teams.

Regulatory Strategy

  • Provide strategic regulatory input and technical guidance on global and/or regional regulatory requirements to product development teams.
  • Support business initiatives by strengthening propositions, influence, and act as a strategic advisor on brand/need state portfolio forums.
  • Provide regulatory risk-based assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the required regulatory requirements and support the proposed product positioning and claims.
  • Participate in cross-functional project teams to define RA resources, development program requirements, and risks.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at regional level.

Regulatory Compliance

  • Maintain awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
  • Communicate changes to appropriate management and cross-functional experts as appropriate.
  • Ensure that all products comply with local regulatory and quality system requirements.
  • Ensure quality and compliance in all actions.
  • Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs, and working instructions.
  • Ensure that the enterprise Regulatory systems are accurate and fully maintained.
  • Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  • Identify and/or implement global/regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with quality function.
  • Support crisis management/PR matters as related to regulatory affairs.

Regulatory Advocacy

  • Monitor the regulatory environment and provide assessments of the impact of new and changing regulations on the company's areas of interest.
  • Actively participate in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at regional level (if relevant).

Team Management

  • Provide technical and leadership development & coaching to build high-performing team.
  • Evaluate deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.

About Kenvue

Kenvue is a global company that realizes the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands 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.

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.

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