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    • Manager - Regulatory Affairs - Mumbai, India - Kenvue

    Kenvue
    Kenvue Mumbai, India

    1 month ago

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    Description

    Job Description

    We are currently recruiting for a Manager Regulatory Affairs position.

    About Us

    Kenvue is a global healthcare company built on over a century of heritage and rooted in science. We are the house of iconic brands, including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and BAND-AID Brand Adhesive Bandages. Our global team is made up of 22,000 diverse and brilliant people who are passionate about insights, innovation, and committed to delivering the best products to our customers.

    Key Responsibilities

    • Regulatory Strategy:
      • Provide regulatory input and technical guidance on local regulatory requirements to product development teams.
      • Support business initiatives by strengthening propositions, influencing, and approving the product portfolio through governance forums.
      • Provide regulatory risk-based assessment and guidance for proposed product claims/labeling, ensuring consistency with required regulatory requirements and supporting proposed product 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.
    • Regulatory Compliance:
      • Maintain awareness of current regulations and anticipate implications and opportunities resulting from changes to relevant regulatory environments.
      • Communicate changes to appropriate management and cross-functional experts as needed and implement locally.
      • Ensure all products comply with local regulatory and quality system requirements.
      • Lead inspections and/or challenges by Authorities and competitors, proposing defense angles in collaboration with relevant experts and framing them with a smart approach.
      • Participate in the development and implementation of, and maintain compliance with, all applicable processes, SOPs, and working instructions.
    • 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 the local level or regional level (if relevant).

    Requirements

    • Relevant Bachelor's Degree or higher
    • Expertise across a broad spectrum of Regulatory classifications, including Cosmetics, Commodities, and/or Medical Devices
    • Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle
    • Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
    • Leadership and coaching skills with experience of people development
    • 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

    What We Offer

    We offer a competitive benefit package, paid company holidays, paid vacation, volunteer time, summer Fridays, learning and development opportunities, employee resource groups, and more.

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