Senior Manager - Quality & Regulatory Affairs (Registered Pharmacist)

Lead Regulatory Affairs, Quality Systems \& Pharmacovigilance across Pharmaceuticals and Medical Devices

Your new company

A well-established healthcare and pharmaceutical organisation with a strong presence in Hong Kong. With a diversified portfolio covering pharmaceuticals, medical devices, and healthcare products, the company is committed to maintaining the highest standards of quality, regulatory compliance, and patient safety. Due to continued business growth, they are now seeking an experienced Senior Manager, Quality Assurance \& Regulatory Affairs to lead the QA/RA function.

Your new role
Reporting directly to the General Manager, you will play a strategic leadership role in overseeing quality and regulatory activities across the organisation.
Key responsibilities include:

* Liaise with the Drug Office and Medical Device Division regarding product registrations, listings, licencing, and regulatory matters.
* Lead and oversee secondary packaging operations in compliance with applicable regulations and quality standards.
* Manage registration, renewal, and tender applications for pharmaceutical products and medical devices.
* Establish, maintain, and continuously improve Quality Management Systems in accordance with ISO 13485, GDP, and other relevant standards.
* Ensure all regulatory documentation, licences, records, and databases remain accurate and compliant.
* Partner with cross-functional stakeholders to develop quality policies, procedures, and compliance initiatives.
* Maintain an effective pharmacovigilance system in accordance with local regulations and company standards.
* Lead, mentor, and develop the Quality Assurance and Regulatory Affairs team.
* Drive regulatory and quality-related projects to support business growth and operational excellence.
* Support ad hoc assignments and strategic initiatives as directed by senior management.

What you'll need to succeed

* Bachelor's Degree in Pharmacy.
* Registered Pharmacist with the Pharmacy and Poisons Board of Hong Kong.
* Minimum 5-10 years of relevant experience in Quality Assurance, Regulatory Affairs, or related pharmaceutical compliance functions.
* Strong knowledge of Hong Kong pharmaceutical regulations, medical device registration, GDP, ISO 13485, and pharmacovigilance requirements.
* Proven experience liaising with regulatory authorities and managing product registrations.
* Demonstrated leadership experience with the ability to lead and develop high-performing teams.
* Excellent stakeholder management and cross-functional collaboration skills.
* Strong problem-solving, communication, and project management capabilities.
* Proficiency in both English and Chinese.

What you'll get in return

* Opportunity to lead a critical QA \& RA function within a reputable healthcare organisation.
* Strategic leadership exposure and direct interaction with senior management.
* Career development opportunities within a growing and stable business.
* Competitive remuneration package with comprehensive employee benefits.
* Collaborative and professional working environment focused on quality and compliance excellence.

What you need to do now
If you're interested in this role, click 'Apply Now' to forward an up-to-date copy of your CV, or contact Kristi Pang at 852 2230 7904 or [email protected] for a confidential discussion.
If this job isn't quite right for you, but you are looking for a new position within the pharmaceutical, medical device, healthcare or life sciences market, please contact us for a confidential discussion about your career.