Regulatory Affairs Manager

 

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.

 

Join us on our One Perrigo journey as we evolve to win in self-care.

 

Description Overview

In this role you will be responsible for hands-on regulatory activities required for submission, approval, and launch of new products, as well as the maintenance of existing commercialized products in the Nordics (SE/DK/FI/NO/IS).

 

You will ensure that products across various categories (medicinal products, medical devices, food, food supplements, and cosmetics) comply with applicable regulatory requirements in the Nordic countries.

 

Another major aspect fo the rol will be to facilitate product introductions (launches) by enabling compliant product claims and removing regulatory barriers in the product listing process with customers.

Scope of the Role

• Execute regulatory activities in line with project plans to ensure that new products meet submission, approval, and commercial launch objectives.

 

• Manage lifecycle activities for products across various regulatory classifications, including handling change controls and the submission of variations and renewals for medicinal products.

 

• Ensure product labeling is maintained in compliance with applicable laws and regulations, including the development and approval of label specifications in accordance with SOPs.

 

• Review and approval of claims and marketing material from regulatory perspective

 

• Liaise and negotiate with Nordic National Competent Authorities (NCAs)

 

• Support manufacturing and procurement in managing changes to existing commercialized products.

 

• Maintain regulatory files and data systems in compliance with SOPs.

 

• Represent regulatory affairs in in cross-functional project meetings

 

• Develop regulatory strategies to support product submissions and new product evaluations.

 

• Act as a local Regulatory Affairs expert across multiple product categories, providing strategic input for product registrations and launches

 

• Providing mentorship and support to Regulatory Affairs Associates, including workload allocation and development planning.

Experience Required

 

• University degree with typically a minimum of 6 years’ experience in regulatory affairs. Experience within OTC is required.

 

• Solid regulatory knowledge across one or more of the following areas: pharmaceuticals, medical devices, biocides, food, and food supplements.

 

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 here

 

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.

 

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