Regulatory Affairs Intern

Regulatory Affairs Intern

What we do

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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.

Role reports to:

Senior Regulatory Affairs Specialist

Location:

Europe/Middle East/Africa, Spain, Community of Madrid, Madrid

Work Location:

Fully Onsite

What you will do

The Regulatory affairs Intern will participate to the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies in Spain. In their role, they will cooperate with Commercial/Marketing teams.

Essential duties and responsibilities

Medicines Regulatory activities

• New marketing authorization activities
• Maintenance activities of existing licenses: preparations of administrative, quality regulatory packages and safety related variations for their submission to Healthcare Authorities (H.A.)

Artwork review and approval with the help of the Regulatory Specialist. Internal Aws tool user.

• Review of promotional materials direct to Healthcare Professionals and consumers.
• New legislation monitoring, impact analysis and communication to business partners.
• H.A. tools: Fraccionamiento (Breaking-up of SPCs and PILs). RAEFAR, LABOFAR

Specific requirements

Cosmetic Regulatory activities:

• Artwork review and approval. Internal Aws tool user.
• Review of the promotional material for Healthcare Professionals, consumers and internal departments
• Scientific advice for promotional materials with the support of the Regulatory contact in the Regional Team
• Product information advice for Consumer affairs and consumer service
• Ensure completion of databases.
• New legislation monitoring, impact analysis and communication to business partners.
• New requests, notification of changes for the maintenance, renewals of National Codes of the CGCOF

Oral care Regulatory activities:

• Renewal of licenses and variations for the maintenance of Hygiene products licenses (dental products)

Medical devices Regulatory activities:

• Review of the promotional material for consumers and submission to the HA for approval: CPS
• Review of the promotional material for consumers: Healthcare Professionals

Job Requirements

Essential knowledge and skills:

• Degree in Pharmacy or similar
• Master in Pharmaceutical Industry
• Fluent English

Core competencies

• Communication & Knowledge sharing
• Functional Competencies
• Driving solutions
• Organization skills
• Strategic thinking
• Proactivity

What’s in it for you

• Competitive Benefit Package

• Flexible work policy

• Learning & Development Opportunities

• Canteen

 

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.