Responsibilities
- Ensure product registrations, licenses, and business activities comply with applicable regulatory requirements and standards.
- Prepare, review, and submit regulatory dossiers and applications to obtain and maintain product approvals.
- Liaise with regulatory authorities and manage inquiries, submissions, and approval processes.
- Review product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.
- Monitor regulatory updates, assess compliance risks, and support audits, inspections, and post-market surveillance activities.
- Collaborate with cross-functional teams to maintain QMS compliance, provide regulatory training, and ensure timely implementation of regulatory requirements.
Requirements
- Any Graduate (Bachelor’s degree in any discipline; preference given to Pharmacy, Life Sciences, or related fields).
- Minimum 3–4 years of experience in Regulatory Affairs within the pharmaceutical or medical device industry.
- Strong knowledge of applicable pharmaceutical and medical device regulations, registration procedures, and compliance standards.
- Proficient in Microsoft Office applications, online research, and virtual communication platforms.
- Fluency in written and spoken Myanmar and English, with strong communication and negotiation skills.
- Excellent organizational, analytical, and problem-solving skills, with strong attention to detail, integrity, and the ability to work independently under pressure.
Other Information
- Salary: Attractive & Negotiable Package
- Working Days: Monday to Friday (8:00 AM to 5:20 PM)
- Off Days: Saturday, Sunday & Public Holidays
- Working Location: Kamayut & Dagon Seikkan Townships, Yangon.
If you are interested in this job, please email your resume to hr@achievecareermyanmar.com or call 09454962773 for other information.