Regulatory Affairs Strategic Lead

2 days ago


Mumbai, Maharashtra, India Kenvue Full time

We are currently recruiting for a Regulatory Affairs Strategic Lead at Kenvue in Mumbai.

Company Overview

Kenvue is a leading house of iconic brands, including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AID Brand Adhesive Bandages. With over a century of heritage and rooted in science, we're passionate about delivering the best products to our customers.

Our global team is made up of ~ 22,000 diverse and brilliant people, committed to insights, innovation and care. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you.

Estimated Salary: ₹45-50 lakhs per annum (varies based on location/region)Job Description

This position reports to Director-Regulatory Affairs and is responsible for acting as a strategic business partner to lead Essential Health portfolio (except Johnson's), Cosmetics (Exports), specific cosmetics brand and self-care drug brands and NPPA related regulatory work for India RA including medical devices.

The successful candidate will contribute to develop innovative RA strategies for New Products introduction, LCM and assessment of competitive claims development in assigned portfolio. They will also proactively identify potential impact of upcoming regulations relevant to Consumer Health portfolio through timely regulatory intelligence with solution-driven approach.

Key Responsibilities include:

  • Contribute to India Regulatory strategy development and ensure timely execution on all deliverables in agile manner including dossier submissions, artwork & claims review, with accuracy and end-to-end mindset, etc
  • Collaborate with business partners to provide regulatory strategies and support for robustness of regulatory compliance in everything we do
  • Lead Regulatory Newsletter by proactively identifying impact through regulatory intelligence and capturing the same in timely manner
  • Ensure compliance and be audit-ready for Internal & External audits
  • 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
  • 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
Required Skills and Qualifications

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

Experience and Skills:

Experience: 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

Skills: 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

Benefits

Kenvue offers a competitive Total Rewards Package*, Paid Company Holidays, Paid Vacation, Volunteer Time & More, Learning & Development Opportunities, Employee Resource Groups, and more.



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