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:

• Bachelors 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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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