Regulatory Affairs Strategist

Perrigo Company plc; Lisboa; Híbrido; EUR 42 000 - 64 000; Tempo integral

Resumo da oferta

Perrigo Company plc in Portugal is seeking a Regulatory Affairs professional to support Cosmetic products and Medical Devices/Medicines regulatory activities across global markets. You will contribute to strategy, prepare technical documentation, manage Cosmetic Product Notifications, and liaise with Notified Bodies and authorities.

The role requires a life sciences degree, 3+ years in regulatory affairs, and fluency in English.

Qualificações

• Bachelor’s Degree in Life Sciences or relevant scientific/technical discipline.
• Minimum 3 years in Regulatory Affairs – position dependant on experience.
• Expertise in Cosmetic Product Regulation and regulatory affairs for medical device or medicines products within consumer healthcare or self-care in EU, US or other markets.
• Fluent in English.

Responsabilidades

• Provide regulatory input to new product development and geo-expansion for assigned portfolio.
• Contribute to regulatory strategy development for innovation projects across markets in scope.
• Prepare technical documentation components for submissions, PIFs and labelling per document management processes.
• Support master label and artwork development and claims review.
• Support registration/notification procedures for certification of new products; communicate with Notified Bodies and authorities as needed.
• Responsible for managing central Cosmetic Product Notifications.
• Support due diligence activities and gap analysis assessments.
• Support handover/transition to LCM following initial launch.
• Build regulatory knowledge via regulatory intelligence, training and networking.

Conhecimentos

Regulatory Affairs

Cosmetic Regulation

Regulatory Strategy

English Fluency

Formação académica

Bachelor’s Degree in Life Sciences

Descrição da oferta de emprego

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Description Overview

In this role you will support Category Innovation & Growth projects by delivering defined regulatory activities for Cosmetic products and either Medical Device/Medicines products.

Scope of the Role

You will Support regulatory strategy development and perform regulatory activities in support of global innovation and growth projects for assigned portfolio and/or projects in a specific Category.

Key Responsibilities

• Provide regulatory input to new product development, geo-expansion and existing product innovation for assigned product portfolio.
• Contribute to regulatory strategy development for innovation projects for all markets in scope (gathering and drafting requirements, identifying pathways to market and supportable claims).
• Prepare technical documentation components for submissions, PIFs and labelling in line with document management processes.
• Support master label and artwork development and claims review.
• Support registration/notification procedures for certification of new products and may communicate with Notified Bodies and regulatory authorities as needed.
• Responsible for managing central Cosmetic Product Notifications.
• Support due diligence activities and gap analysis assessments.
• Support smooth handover/transition to LCM following initial launch.
• Build regulatory knowledge via regulatory intelligence, training and networking.

Experience Required

• Bachelor’s Degree in Life Sciences or relevant scientific/technical discipline.
• Minimum 3 years in Regulatory Affairs – position dependant on experience.
• Expertise in Cosmetic Product Regulation and a demonstrated practical experience of regulatory affairs for medical device or medicines products within consumer healthcare or self-care in EU, US or other markets.
• Fluent in English.

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

Hybrid Working Approach

We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo