Job Description

RESPONSIBILITIES

• Handle submission of new products applications and renewal of products with regulatory authorities as assigned.
• Initiate, monitor and report regulatory trials in the North.
• Handle submission of changes to products with regulatory authorities.
• Evaluates technical and scientific information, references, dossiers, provided in support of product claims and attributes.
• Back-up Point of pharmacovigilance contact and Manages adverse events processes, adverse-event case reports and Product Quality Complaint;  notifies regulatory agencies and business partners accordingly; ensures document filing and archiving during the absent of DPOC.
• Review local pharmacovigilance procedures based on company's procedures and prevailing regulations.

PRODUCTIVITY / KEY RESULT AREAS

• Obtain regulatory approval within optimum timelines and subsequently ensure new products are made accessible in the fastest time possible.
• Develop and implement services to assist in delivering better value to customers.
• Contributes to ensure compliance of pharmacovigilance activities: assures compliance of pharmacovigilance activities; conducts case reconciliation with concerned departments or business partners.

GENERAL QUALIFICATION GUIDELINES

Experience and education

• Ideally a veterinary graduate or related fields
• Prior experience in veterinary industry as Regulatory Affairs Executive at least 3-5 years.

Knowledge, skills, and abilities

• Familiar with policies and procedures of Ministry of Agriculture (Department of Animal Health, Department of Fisheries, Department of Livestock Productions)
• Good working knowledge of applicable Laws and Regulations.
• Relevant knowledge of products
• Well organized
• Competent in written and spoken English language.
• Strong verbal and written communication skills, and a demonstrated ability to work in a team environment

QUALITATIVE FACTORS

• High motivation level with strong drive to achieve results and contribute to company's profitability.
• Highly ethical. Honestly.
• Reliability.
• Accountability.
• Loyalty.
• Ability to constantly add value to customers needs (both internal and external).
• Ability to constantly improve personally.
• Professional personal appearance.
• Ability to offer ideas and accept ideas of others.
• Teamwork: must have the ability to work efficiently and effectively within a team environment.

 

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:

04/15/2025

*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.