REGULATORY AFFAIRS MANAGER / ASSISTANT REGULATORY AFFAIRS MANAGER - pharmaceutical distribution company (Wanchai)

COMPANY OVERVIEW 

• We are a professional pharmaceutical distribution company with a long history in Hong Kong.

• Over the years, we have built a strong reputation in the healthcare industry by supplying quality pharmaceutical products and healthcare solutions to hospitals, clinics, pharmacies and other healthcare customers in Hong Kong and Macau.

• Our business covers product registration, import and distribution, warehousing, sales and marketing, regulatory compliance and customer service. We work closely with international pharmaceutical manufacturers and suppliers to ensure that products are safely imported, properly registered and distributed in accordance with local regulatory requirements.

• We are committed to maintaining high standards of quality, compliance and professional service, while providing employees with a stable working environment and opportunities to develop their careers in the pharmaceutical sector.

ROLE MISSION

• You will independently manage the company’s regulatory affairs activities. 

• You will ensure that pharmaceutical products are properly registered, maintained and distributed in compliance with the regulatory requirements of Hong Kong and Macau.

ROLE SUMMARY

• You will be fully responsible for regulatory registrations, documentation, compliance and post-market reporting. 

• You will also support quality-related activities, manage regulatory procedures, and act as the main regulatory contact for internal departments, suppliers and government authorities.

JOB DESCRIPTION

• Work independently and take full responsibility for all regulatory affairs matters of the company.

• Prepare, submit and follow up new product registration applications, including New Drug Applications (NDAs) and generic product registrations.

• Maintain and update regulatory documents, product licences, registration records and related files.

• Ensure compliance with local pharmaceutical laws, regulations and registration requirements in Hong Kong and Macau.

• Assist in qualification and validation activities in accordance with Good Manufacturing Practice (GMP) requirements.

• Develop, review and manage Standard Operating Procedures (SOPs) relating to regulatory filings and submissions.

• Support regulatory inspections and provide the required documents and information to authorities.

• Handle post-market reporting to the Department of Health and overseas suppliers.

• Liaise with suppliers, regulatory authorities and internal departments on regulatory matters.

• Provide professional regulatory advice and support to sales, procurement, quality assurance and other internal teams.

• Monitor regulatory updates and advise management on any changes that may affect the company’s products or operations.

• Perform other duties as assigned by management.

IDEAL CANDIDATE

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Health Sciences, Life Sciences or a related discipline.

• At least 3 years’ regulatory affairs experience in the pharmaceutical industry is essential.

• Solid knowledge of pharmaceutical product registration, regulatory documentation and compliance requirements.

• Strong knowledge of local laws and regulations in Hong Kong and/or Macau.

• Experience in handling NDAs, generic product registrations, GMP-related activities and regulatory inspections is preferred.

• Good communications in written and spoken English and Chinese.

• Able to work independently, manage multiple priorities and take full ownership of regulatory matters.

TERMS & BENEFITS

• 5-days work; Monday to Friday, 9:00 a.m. – 5:30 p.m.

• 12 days’ annual leave.

• Medical and dental insurance.

• Work-life balance and supportive work culture.

TO APPLY for this job or similar jobs :

Please email your CV with salary expected to [email protected]

JPC Recruiting Services was established in 1990 and is a Hong Kong–based recruitment firm providing general recruitment and executive search services.
JPC Recruiting Services 於 1990 年成立，是一家總部設於香港的專業招聘公司，提供招聘及獵頭服務。

All personal data collected from job applicants will be used strictly for recruitment purposes only. Your privacy is fully protected, and your personal information will not be disclosed, leased, or sold to any third party.
本公司所收集的求職者個人資料僅作招聘用途。閣下的私隱將獲得嚴格保障，個人資料絕不會被披露、出租或出售予任何第三方。

Thank you for your application.  Please email us if you have any question.