Senior Regulatory Affairs Manager

1 week ago

Mumbai, Maharashtra, India Kenvue Full time
Job Summary:

This role is for a strategic business partner to lead the Essential Health portfolio, Cosmetics (Exports), specific cosmetics brand, and self-care drug brands and NPPA related regulatory work for India RA including medical devices.

Main Responsibilities:
  1. Contribute to the development of innovative RA strategies for New Products introduction, LCM, and assessment of competitive claims development in assigned portfolio.
  2. Proactively identify potential impact of upcoming regulations relevant to Consumer Health portfolio through timely regulatory intelligence with solution-driven approach.
  3. Keep up-to-date on current changes in the environment of regulations in various markets on regulatory policy related to cosmetics, commodities, drugs, and medical devices and support Leadership appropriately for advocacy in related regulations and any other regulations shaping in India.
  4. Collaborate with business partners to provide regulatory strategies and support for robustness of regulatory compliance in everything we do.
  5. Lead Regulatory Newsletter by proactively identifying impact through regulatory intelligence and capturing the same in a timely manner.
  6. Ensure compliance and be audit-ready for Internal & External audits.
  7. Lead team by ensuring timely response to regulatory queries including CDSCO, State Drug Control offices, ASCI, Legal Metrology, NPPA, etc for effective closure of queries without impacting business.
  8. Ensure getting self and team adequately trained and developed. Ensure that an active coaching and development culture operates in the regulatory team with cross-skilling and information/knowledge sharing.

Requirements:

Education: Master's in pharmacy/science with PG Diploma/certification in Regulatory Affairs

Experience and Skills:
  1. Minimum 12 to 15 years in Indian cosmetics, drugs (including NPPA related work), medical devices, and commodities Regulatory domain. Experience of handling food-related regulatory work would be considered as a value addition.
  2. Adequate regulatory and technical knowledge in cosmetics, drugs, medical devices, and commodities portfolio, proficiency in law interpretation skills, effective interpersonal skills, and with high adaptability, in a complex environment with strong work ethics.

What We Offer:
  1. Competitive Total Rewards Package*
  2. Paid Company Holidays, Paid Vacation, Volunteer Time & More
  3. Learning & Development Opportunities
  4. Employee Resource Groups
  5. This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

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