PHARMAFull-time
Sr. Spclst, Regulatory Affairs
LISBON (PT)HYBRIDPOSTED: 8/8/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK & CO., INC.Technology
ROLE DEFINITION & RESPONSIBILITIES
Review and approve Quality documentation for incoming goods while verifying transportation conditions and upholding Good Documentation Practices.
Oversee Quality System operations, managing deviations, CAPAs, change controls, customer qualification requests, and returned goods.
Track Quality Metrics, support 3PL compliance monitoring, and contribute to Quality System Reviews.
Ensure full compliance with Good Distribution Practices, company policies, and EU regulatory requirements for animal health products.
Prepare, submit, and track Marketing Authorization applications, along with managing product variations, renewals, and supplemental authorizations.
Direct labeling translations and artwork preparation, partnering with cross-functional teams to align regulatory strategy with business goals.
REQUIRED VERIFIED 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
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Merck & Co., Inc. is actively hiring for this position.
INDUSTRY: Technology
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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