Company Profile:

: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments

Job description:

Position Summary

EMEA Raw Material Regulatory Sr. Scientist which includes below responsibilities:

• Coordinate and ensure quality of the review & approval for Raw Materials & formula for regulatory clearance in Concerto through collaboration the external resources (IMED) and internal RMC team
• Regulatory approval for GCC (Global Change Control) related to raw materials and perform impact assessment for Raw material changes like alternate supplier qualification, supplier driven changes etc. with help of local RA
• Support to ingredient issues and policies for EMEA region under guidance from Global RMC Regulatory Lead
• Closely work with Regional Regulatory Affairs to implement new ingredient regulatory requirements in the portfolio and integrate to raw material and formula regulatory clearance process
• Support to data management team for impact assessment for changes in the raw material data
• Collaborate with local Regulatory Affairs (RA) team to understand the country specific Regulatory requirements and help the qualification team to manage the Raw material changes efficiently and in compliance.
• Bring in process improvement ideas and drive simplifications to create a strong relationship with key stakeholders.
• Develop an agile mindset within the team and drive agile new ways of working with stakeholders across R&D, Quality, and Supply Chain.
• Collaborate with RMC RA team, Stewardship and Regulatory Affairs to support anticipation of ingredients issues and defense
• Work with the team to define process, RACI and increase overall compliance to Chemical Regulations in EMEA

 

 

Required Knowledge, Skills and Abilities:

• Proficiency in Microsoft office tools,
• Experience in change control management process
• Knowledge of raw materials and its impact on the personal care formulations
• Adequate knowledge of GxP & quality systems
• Regulatory Experience Preferred
• Excellent communication, organizational, and interpersonal skills
• Ability to collaborate with internal and external resources to meet project objectives.
• Understanding on raw material chemistry and its usage and function in finished products
• Proficiency in Microsoft office
• Ability to manage/resolve interpersonally challenging situations
• Ability to successfully navigate unknown/unforeseen challenges