Regulatory Affairs Specialist

Job Description

POSITION OVERVIEW: BASIC FUNCTIONS & RESPONSIBILITIES

This position is responsible to regulatory-related projects, tasks, as well as providing guidance to ensure compliance with Vietnam regulations 

PRIMARY ACTIVITIES 

• Prepares and oversees documentation packages for submission to Vietnamese regulatory agencies; tracks timelines and key milestones to ensure timely submissions; liaise with regulatory agencies during the review process. 

• Monitors proposed and current Vietnamese regulations and guidance and assess their impact on company products and activities.  

• Review product labeling and promotional materials to ensure compliance with applicable regulation.  

• Prepare Vietnamese labels in accordance with local regulations.  

• Act as Pharmacovigilance contact point for Vietnam 

• Collaborate with other departments to manage regulatory inspections and testing of incoming Vet medicine shipments 

EDUCATION, EXPERIENCE & COMPETENCIES 

Education: Bachelor’s degree in veterinary science, Animal Health, Biotechnology or related fields. 

Experience: 3 years of experience in a regulatory role or related area.  

Competency:  

• Fluent English with strong written and verbal communication skills.  

• Excellent analytical and problem-solving skills.  

• Experience working on cross functional projects. 

Additional requirements:  

• Hardworking, honest and responsible in work.  

• Adaptable to dynamic environments. Capable of working under pressure and meeting deadlines. 

Required Skills:

Adaptability, Adaptability, Animal Husbandry, Biological Sciences, Biotechnology, Cross-Team Coordination, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Immunochemistry, Microbiology, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Pressure Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Inspections, Regulatory Project Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing {+ 1 more}

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:

05/16/2026

*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.