Regulatory Affairs Specialist - Animal Health

Job Description

Regulatory Affairs Specialist

Position Summary: We are seeking a detail-oriented and committed Regulatory Affairs Specialist to join our team. The successful candidate will ensure that our veterinary products comply with regulatory requirements across Central America, the Caribbean, Ecuador, and Venezuela, facilitating product registrations and maintaining regulatory approvals throughout the product lifecycle.

 

Key Responsibilities

• Prepare, review, and assure submission of regulatory documentation for veterinary product approvals.

• Maintain the current product portfolio through management of renewals and post-registration changes.

• Ensure product labeling remains compliant and up to date; coordinate with internal teams to implement labeling changes on schedule and maintain regulatory compliance during commercialization.

• Manage and respond to inquiries and requests from regulatory authorities in a timely manner.

• Monitor and coordinate with third parties regarding required submissions and approvals.

• Update and maintain internal regulatory tools and documentation.

• Contribute to the development of regulatory strategies for new products and modifications to existing products.

• Stay informed of changes to national and international regulations and assess their impact on the business.

 

Education & Experience

• University degree in Pharmacy, Veterinary Medicine, or related fields.

• Minimum of 2 years’ experience in regulatory affairs, preferably in the veterinary pharmaceutical industry.

• Strong knowledge of national and international regulatory frameworks relevant to veterinary products.

• Ability to manage multiple projects.

• Intermediate to advanced level of English.

Skills

• Effective communication skills and the ability to work collaboratively across functions

• Excellent organization and time-management abilities.

• High attention to detail and accuracy.

• Proactive attitude and strong analytical skills.

• Professional ethics and strict confidentiality.

Required Skills:

Adaptability, Adaptability, Communication, Cross-Team Collaboration, Detail-Oriented, Documentations, Electronic Common Technical Document (eCTD), Employee Training Programs, Labeling Compliance, Leadership, Multi-Management, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Portfolio Management, Product Registrations, Professional Ethics, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions {+ 3 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

04/6/2026

*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.