Sr. Spclst, Regulatory Affairs

Job Description

An amazing opportunity has arisen for a Quality & Regulatory Specialist in our company Animal Health Portugal.

This position will be responsible for supporting Quality and Regulatory activities across incoming goods and distribution operations, ensuring compliance with applicable standards and requirements.

Working with cross-functional teams and external logistics partners, the role will contribute to Quality System performance, compliance monitoring, and key regulatory submissions and product maintenance activities.

What you will do:  

Bring energy, knowledge, innovation and leadership to carry out the following:

• Review and approve Quality documentation for incoming goods, ensuring accurate records retention in line with Good Documentation Practices, and verifying transportation conditions from the manufacturing site.
• Manage and track Quality System activities including deviations, CAPA, change controls, customer qualification requests, and returned goods.
• Prepare Quality Metrics, contribute to the Quality System Review, and participate in 3PL compliance monitoring.
• Execute quality activities required by Good Distribution Practices, Corporate Policies, and applicable EU regulatory requirements for products marketed by our company Animal Health Portugal.
• Ensure timely preparation, submission, and follow-up of Marketing Authorization applications, and maintain authorized products through variations, renewals, and supplemental authorizations.
• Ensure timely, accurate, and compliant labelling translations and artwork preparation, partnering with cross-functional teams to implement local regulatory strategies and manage regulatory risks.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Review and approve Quality documentation for all incoming goods, verify transportation conditions from the manufacturing site, and ensure accurate documentation and record retention in line with Good Documentation Practices.
• Manage and track Quality System activities, including internal deviations, CAPA, change controls, customer qualification requests, returned goods, and other related activities.
• Prepare Quality Metrics, contribute to the Quality System Review, and support 3PL compliance monitoring.
• Execute quality activities required by Good Distribution Practices, Corporate Policies, and applicable EU regulatory requirements for products marketed by our company Animal Health Portugal.
• Ensure timely preparation, submission, and follow-up of new Marketing Authorization applications to local authorities, and maintain authorized products through variations, renewals, and supplemental marketing authorizations.
• Ensure timely, accurate, and compliant labelling translations and artwork preparation, partnering with cross-functional teams to implement local regulatory strategies, identify regulatory risks, and align with business objectives.

Why Join Us?

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

So, if you are ready to make a meaningful impact on quality and compliance, by helping ensure our products reach customers safely and reliably, please apply today.

Required Skills:

Clinical Development, Drug Regulatory Affairs, Pharmaceutical Quality Assurance, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Quality Assurance Processes, Quality Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Risk, Regulatory Submissions

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/15/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.