Regulatory Affairs Specialist Lisboa

Regulatory Affairs Specialist
Lisboa
Lisboa, Lisboa, Portugal

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.

Job Description - Regulatory Affairs Specialist (2507030203W)

Kenvue is currently recruiting for a Regulatory Affairs Specialist.

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, 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 of 22, 000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact the lives 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.

What You Will Do:

The Regulatory Affairs Associate oversees a range of regulatory activities for their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post-approval and new submissions), resolution of Health Authority questions in cooperation with other functions,
- approval commitments and submission of variations/renewal applications where requested.

The Roles & Responsibilities include:

Regulatory Strategy

• Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
• Collects and organizes information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
• Prioritizes, plans and monitors allocated projects against defined timelines.
• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.

Regulatory Compliance

• Assists in the maintenance of compliance for all products with local regulations and quality system requirements.
• Ensures that all assigned products comply with local regulatory and quality system requirements.
• Reviews and approves promotional materials for assigned local Kenvue products.
• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
• Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
• Identifies & initiates local process improvement opportunities and manages changes as required.
• Assists in the preparation for internal and external audits and inspections in collaboration with others.

What we are looking for:

• Knowledge of consumer healthcare environment and product development.
• Understanding of processes and departments within a healthcare company.
• Effective time and organization management.
• Proficiency in English.
• Excellent oral and written communication skills.
• Able to work under pressure and to tight deadlines.
• Able to work on own initiative.
• Analytical thinker.
• Able to work effectively in a
  - cultural, highly matrixed organization.

What’s in it for you:

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Employee Resource Groups.
• Hybrid working available (e. g. 2 days in office, 3 days from home).

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 identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

Europe/Middle East/Africa-Portugal-Lisbon-Lisbon