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Regulatory Affairs Project Manager

Location: 

Carnaxide, PT, 2790-255

 

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

 

As Regulatory Affairs Project Manager who will lead and execute regulatory strategies across multiple product categories, ensuring timely submissions, compliant product information, and seamless lifecycle management while also contributing to safety monitoring and GDP‑aligned quality processes.

This role will be ideal for a detail‑oriented professional who thrives in dynamic, multi‑category environments.

Scope of the Role

 

Regulatory Affairs

  • Support and execute regulatory activities according to project plans to ensure timely regulatory submissions, approvals, and product launches;
  • Actively contribute throughout the product lifecycle, including NPD, launches, lifecycle maintenance, and promotional activities;
  • Maintain compliant product labeling and packaging specifications across multiple product categories;
  • Modification of registration processes as necessary for specific country regulatory requirements and supervision of the submission of registration/variation applications and negotiation with government authorities to obtain expedited approvals;
  • Manage change requests in compliance with GDP and regulatory standards;
  • Maintain regulatory files and data systems in accordance with SOPs;
  • Collaborate effectively with Marketing, Trade Marketing (CS&I), Sales, Central Regulatory, and Innovation;
  • Translate global documentation into national versions scientific language;
  • Provide regulatory support across cosmetics, medical devices, food supplements, and biocides;
  • Manage authority and notified body feedback in a timely manner;

 

Drug Safety Management

  • Collect, evaluate, and report adverse events and adverse product reactions;
  • Coordinate actions to address identified or potential safety risks;
  • Review Global Medical Affairs reports relevant to Portugal and implement required measures;

 

Quality Support

  • Support on GDP tasks, ensuring compliant storage, handling, admin batch release, and product reworks
  • Handling of data for the effects of QMR
  • Support during HA audits
  • Management of CAPAs, non-conformities and deviations

Experience Required

 

  • Strong communication and project management skills
  • 4+ years industry experience
  • Ability to work autonomously and within international teams
  • Detail‑oriented, problem‑solving skills, able to translate regulatory complexity into clear, actionable messages
  • Not mandatory: technical knowledge of Module 3 management

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.)  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

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