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IDMP Regulatory Data and Business Process Lead

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Job Description


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, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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®.

Key Responsibilities:

  • Lead the information gathering on IDMP, primarily from EMA and other Regulators as new guidance and specifications become available and determine how to translate to J&J Consumer IDMP programme.
  • Shape and optimise the strategy for IDMP implementation for J&J Consumer leveraging understanding of Regulatory business processes within J&J.
  • Develop and maintain execution workstreams and lead team of resources to map and develop IDMP data for the EEA Self Care portfolio.
  • Adapt plans and activities as project moves through development into implementation phases.
  • Identify linkages between IDMP and adjacent Regulatory Initiatives and be the Regulatory Champion for IDMP in the organisation.
  • Link with Regulatory Affairs teams to ensure alignment and to propose updated processes where needed.
  • Develop business processes for IDMP use cases and work closely with programme lead and IT leads to implement for production.
  • Liaise with Supply Chain lead to develop SC data integration plan for IDMP submission.
  • Develop Life Cycle Management process for IDMP, partnering with Supply Chain, Quality Systems, RA and R&D teams.
  • Partner with IT lead and programme lead to identify, pilot and implement technology tools and data analytics requirements as needed to support an efficient means of implementing IDMP and ensuring effective data linkage E2E.
  • Connect with adjacent projects across Consumer and J&J enterprise where needed.


Qualifications

Required:

  • 5 years + experience in a regulatory affairs operational role in pharmaceutical industry.

Preferred:

  • Understanding and hands on experience of electronic submission process, MAH, Variations or regulatory information management or external regulatory process preferred.
  • Understanding and of IDMP standards and / or xEVMPD and Article 57 medicinal product data requirements.

Other:

  • Experience working in a matrixed environment with teams spanning geographical regions countries and time zones
  • Proven leadership and analytical skills.
  • Excellent interpersonal and intercultural communication skills.
  • Experience and track record building and leading teams through project phases from concept to implementation

Primary Location
India-Andhra Pradesh-Hyderabad-
Organization
Johnson & Johnson Private Limited (8080)
Job Function
Regulatory Compliance
Requisition ID
1905786424W