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: Bachelor’s degree in Pharmacy, Pharmacology, or Life Sciences (Master’s degree is an advantage) .
• Experience: Minimum 3–5 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, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.