Regulatory Affairs Specialist

Main Life Corp Ltd; Hong Kong; On-site; HKD 550,000 - 750,000; Full time

Benefits offered by this job

Performance bonus

Medical insurance with dental

Other fringe benefits

Job summary

Main Life Corporation Ltd is seeking a Regulatory Affairs professional to work independently to obtain new product registrations including NDAs and generic products, and to maintain regulatory documentation while ensuring compliance with local regulatory requirements in a pharmaceutical distribution environment.

The role includes preparing submissions, assisting GMP-related qualification and validation activities, managing SOPs, supporting regulatory inspections, and post-market reporting to DOH

Qualifications

• Bachelor degree in health, pharmaceutical or related disciplines.
• Minimum of 3 years experience in regulatory affairs in pharmaceutical companies.
• Excellent knowledge of local laws and regulations in Hong Kong and Macau.
• Proficiency in both written and spoken English and Chinese.

Responsibilities

• Obtain new product registrations including NDAs and generic products.
• Maintain regulatory documentation and ensure compliance with local regulatory requirements.
• Assist in qualification and validation activities in accordance with GMP requirements.
• Manage SOPs related to regulatory filings and submissions.
• Support regulatory inspections.
• Post-market reporting to DOH and suppliers.
• Technical contact for internal department.

Skills

Regulatory affairs

Documentation management

GMP knowledge

Communication skills

Education

Bachelor degree in health, pharmaceutical or related disciplines

Job description

Work independently to obtain new product registrations including NDAs and generic products, maintain regulatory documentation, and manage compliance with local regulatory requirements in a pharmaceutical distribution environment.

Key responsibilities

• Work independently to obtain new product registrations including NDAs and generic
• Maintain regulatory documentation and managing compliance with local regulatory requirements
• Assist in qualification and validation activities in accordance with GMP requirements
• Manage SOPs related to regulatory filings and submissions
• Support regulatory inspections
• Post-market reporting to DOH and suppliers
• Technical contact for internal department

About you

• Bachelor degree in health, pharmaceutical or related disciplines
• Minimum of 3 years experience in regulatory affairs in pharmaceutical companies
• Excellent knowledge of local laws and regulations in Hong Kong and Macau
• Proficiency in both written and spoken English and Chinese
• Hardworking and self-motivated
• 5-day workweek
• Performance bonus
• Medical insurance with dental
• Other fringe benefits

About us

Main Life Corporation Ltd is a Pharmaceutical Distributor at Central since 1971.