Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products, and services to advance the health and well-being of people. Every day, more than 130,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

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Our Consumer Business touches a billion lives around the world and works with the vision of ‘Bringing science to the art of healthy living’. In India, the company touches the lives of consumers through businesses spanning baby care, women’s health, beauty, oral & wound care, and over-the-counter-products which are endorsed by healthcare professionals around the world. In India, the company touches the lives of consumers through Baby Care, Women’s Health, Beauty, Oral & Wound Care, and OTC. Some of our key brands include Johnson’s® Baby, Stayfree®, Clean & Clear™, Band-Aid®, Listerine®, ORSL, and Benadryl®.

Position: Associate Manager – Regulatory Affairs

Location: Mumbai, Maharashtra

Job Description:

Purpose of the Position:

  • To act as a strategic business partner to support the Selfcare (Drug) portfolio for India RA.
  • Contribute to developing innovative RA strategies for New Products, LCM and assessment of competitive claims development in self-care (drugs)
  • Proactively identify the potential impact of upcoming regulations through timely regulatory intelligence with a problem-solving approach
  • Up to date on current changes in the environment of regulations in various markets on OTC policy, and support Leadership appropriately for advocacy on OTC regulation in India

Key Responsibilities:

  • Contribute in India-Selfcare Regulatory strategy development and ensure timely execution on all deliverables in an 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 the robustness of regulatory compliance in everything we do.
  • Ensure compliance and be audit Ready for Internal & External audits.
  • Ensuring timely responding to regulatory queries including CDSCO, State Drug Control offices, ASCI, etc
  • Ensure getting adequately trained and developed. Ensure that an active coaching and development culture operates in the regulatory team with cross-skilling and information/knowledge sharing

Skills & Knowledge:

  • Adequate regulatory and technical knowledge in Selfcare,
  • Proficiency in law interpretation skills, effective interpersonal skills, and with high adaptability, in a complex environment with strong work ethics

Qualification: B.Pharma, M.Pharma, PG Diploma in Regulatory Affairs

Experience: 8-10 Years in RA of India, Experience in Handling Food & Cosmetic is Added Advantage

Salary: Negotiable

Contact Details:

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