Assistant Manager, Regulatory-Hongkong

About the Opportunity Novo Nordisk Hong Kong is seeking a proactive and detail-oriented Assistant Manager Regulatory & Pharmacovigilance to join our Regulatory department. This role is heavily focused on regulatory operation; you will play a vital operational role in directly preparing and managing regulatory submissions maintaining product lifecycles and ensuring rigorous compliance for Hong Kong and Macau while also overseeing essential pharmacovigilance activities.

Key Responsibilities

• Regulatory Execution: Act as the primary point of contact for health authorities and lead the hands-on preparation and coordination of meeting requests responses and commitments.
• Submissions Management: Coordinate the collection of documents and lead the preparation of submissions for product approvals including NCEs post-approval variations renewals and import licenses.
• Compliance & Lifecycle: Maintain local processes for labelling and packaging compliance and conduct regulatory impact assessments for manufacturing and artwork changes.
• Pharmacovigilance (PV): Support and ensure pharmacovigilance activities are processed in compliance with local regulations including handling ICSRs PSURs and safety oversight on patient support programs.
• Cross-Functional Collaboration: Partner with Quality Supply Chain and Commercial teams to translate regulatory requirements into actionable plans.

Who We Are Looking For

• Education: Bachelors degree in Pharmacy Pharmacology or Life Sciences (Masters degree is an advantage) .
• Experience: Minimum 35 years of experience in regulatory affairs product registration and compliance.
• Technical Knowledge: Practical experience coordinating regulatory submissions and responding to HA questions with working knowledge of Hong Kong and Macau regulatory pathways.
• Languages: Fluency in both written and spoken English and Chinese (Cantonese /- Mandarin) .
• Skills: Strong attention to detail analytical skills and the ability to work independently in a fast-paced environment.

We commit to an inclusive recruitment process and equality of opportunity for all our job ap-plicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant cu-riosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you be-come part of something bigger a legacy of impact that reaches far beyond today.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.