Regulatory Affairs Specialist

Job Description

Key responsibilities:

• Providing support to regulatory related timely submissions and registration maintenance, other activities assigned as appropriate

• Responsible for dossier compilation to ensure ready to submit dossier is available as per local country requirements

• Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.

• Monitor and manage product registration and life cycle management

• Ensure labelling compliance

• Support promotional material processes

• Ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards

• Liaise with Global/Regional RA and local Regulatory Authority to ensure full local regulatory and company compliance

• other duties as assigned.

Qualification and Education:

• Bachelor’s Degree in Pharmacy (Pharmaceutical science).

• 5-7 year experiences in regulatory administration or documentation is preferable.

• Actively responsible and well-organized.

• Positive attitude and passion on regulatory work and document.

• Good communication and interpersonal skills.

• Outstanding skills in MS Word, MS Excel, Internet, E-mail, PDF, typing both Thai & English.

• Competency in problem solving and handle issues with Thai FDA and DLD

• Good command in English both written and spoken

Required Skills:

Accountability, Accountability, Adaptability, Biomedical Sciences, Communication, Detail-Oriented, Documentations, Electronic Common Technical Document (eCTD), Employee Training Programs, Mentorship, Pharmaceutical Microbiology, Pharmaceutical Regulatory Affairs, Pharmaceutical Sciences, Pharmacovigilance, Product Lifecycle Management (PLM) Systems, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Awareness, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Oversight, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions {+ 2 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:

11/14/2025

*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.