Description

Kenvue is currently recruiting for:

Regulatory eXVMPD Coordinator

This position reports into Director Regulatory Affairs Self Care and is based at Greater Mumbai/ Prague.

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22, 000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .

The Regulatory eXVMPD Coordinator provides data gathering, data entry and data QC support for xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) in compliance with EMA's Article 57(2) Regulation.

What You Will Do

Key Responsibilities

• Provision of tactical and strategic support for the IDMP / ISO SPOR program by providing subject matter expertise and performing data evaluation and remediation activities.

• Creation and maintenance of RA data management processes, procedures and work instructions.

• Support continuous improvement of data and processes.

• Provides support for internal audits, HA inspections and corrective action plans

• Recognizes and reports data compliance issues and how they impact assigned processes

• Executes operational aspects of enabled processes according to Client's procedures

What We Are Looking For

Required Qualifications

• Relevant bachelor's degree or higher

• Demonstrates experience and understanding of the procedures and decision-making process of the Health Authorities around medicinal products in Europe.

• Strong understanding of regulatory operations

• Knowledge and experience with computer systems in an R& D environment including eXVMPD

• Understanding of system validation, testing methods, GMP guidelines and electronic records regulations

• Experience in dealing with internal customers and supervising external contractors

Desired Qualifications

• Proficiency in English

• Excellent oral and written communicator

• Able to work under pressure and to tight time deadlines

• Able to work under own Initiative

• Analytical thinker

• High proficiency with Microsoft suite of products

• Able to work effectively in a multi-cultural, highly matrixed organization

• Effective time and organization management.

What's In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.