Job Description

POSITION OVERVIEW: BASIC FUNCTIONS & RESPONSABILITIES/

This role plays a critical part in supporting geo-expansion initiatives, where Quality compliance and documentation are essential for successful product registration and launch. Responsibilities include ensuring accuracy, completeness, and timely provision of Quality-related documents such as product specifications, analytical methods, composition details, Certificates of Analysis (CoA), and stability reports.

PRIMARY ACTIVITIES

Regulatory Submission & Compliance

• Prepare, review, and maintain product registration dossiers for export markets, including product documents (composition, specifications, CoA, stability data, analytical methods,…) and Administrative documents (PoA, CFS,..), ensuring completeness and alignment with regulatory requirements

• Coordinate with cross-functional teams and external partners to collect required data and support submissions across APSA and LATAM markets

• Monitor registration status, manage variations and updates, and ensure timely renewal of product licenses in compliance with local regulations

• Support preliminary review of artwork content and track release progress to ensure alignment with product launch timelines

Cross-functional Coordination

• Liaise with local partners and regulatory consultants to support registration activities.

• Collaborate with QA/QC, Regulatory, Supply Chain, and Manufacturing teams to support seamless execution of launch plans.

Desired Experience/Education/Skills:

• Education: Bachelor’s degree in Veterinary Science, Biotechnology, Chemistry or related fields.

• Experience: At least 03 years of experience working in Quality or Regulatory team.

• Skills:

• Strong communication skills: essential for coordinating various teams and stakeholders

• Project Management expertise: Ability to manage complex projects and meet deadlines

• Proficient in English and Microsoft Office Suite (Word, Excel, Power Point).

Additional requirements:

• Hardworking, honest and responsible in work

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

Required Skills:

Analytical Method Qualification, Audits Compliance, Compliance Implementation, Computer Literacy, Employee Training, GMP Compliance, Manufacturing Processes, Manufacturing Quality Control, Policy Development, Quality Assurance Systems, Quality Improvement Programs, Quality Leadership, Regulatory Reporting, Regulatory Training, Technical Writing

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/8/2026

*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.