Regulatory Affairs Specialist: Dossier Submissions & Compliance

Bright Prospect; Selangor; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading life sciences company in Petaling Jaya, Selangor, is seeking a candidate for a Regulatory Affairs position. The role involves preparing regulatory submissions, managing license maintenance, and ensuring compliance with regulations. Ideal applicants should have a Bachelor's degree in Pharmacy or related fields, with some experience in Regulatory Affairs being preferred. Fresh graduates are also encouraged to apply. Strong communication and project management skills are essential for success in this position.

Qualifications

• Bachelor’s degree in Pharmacy or a related Life Sciences field required.
• 1–2 years of work experience in Regulatory Affairs preferred.
• Fresh graduates are welcome to apply.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registrations.
• Manage labeling revisions and CMC updates for licenses.
• Respond to queries from regulatory authorities.

Skills

Detail-oriented

Strong communication skills

Project management skills

Adaptability

Proactivity

Education

Bachelor’s degree in Pharmacy or related Life Sciences

Job description

A leading life sciences company in Petaling Jaya, Selangor, is seeking a candidate for a Regulatory Affairs position. The role involves preparing regulatory submissions, managing license maintenance, and ensuring compliance with regulations. Ideal applicants should have a Bachelor's degree in Pharmacy or related fields, with some experience in Regulatory Affairs being preferred. Fresh graduates are also encouraged to apply. Strong communication and project management skills are essential for success in this position.