Assistant Manager, Regulatory
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Hong Kong • Hong Kong
Visit company websiteExplore more
About the role
- Act as the primary point of contact for health authorities and lead the hands-on preparation and coordination of meeting requests, responses, and commitments.
- Coordinate the collection of documents and lead the preparation of submissions for product approvals, including NCEs, post-approval variations, renewals, and import licenses.
- Maintain local processes for labelling and packaging compliance and conduct regulatory impact assessments for manufacturing and artwork changes.
- Support and ensure pharmacovigilance activities are processed in compliance with local regulations, including handling ICSRs, PSURs, and safety oversight on patient support programs.
- Partner with Quality, Supply Chain, and Commercial teams to translate regulatory requirements into actionable plans.
Requirements
- Bachelor’s degree in Pharmacy, Pharmacology, or Life Sciences (Master’s degree is an advantage)
- Minimum 3–5 years of experience in regulatory affairs, product registration, and compliance.
- Practical experience coordinating regulatory submissions and responding to HA questions, with working knowledge of Hong Kong and Macau regulatory pathways.
- Fluency in both written and spoken English and Chinese (Cantonese +/- Mandarin).
- Strong attention to detail, analytical skills, and the ability to work independently in a fast-paced environment.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsproduct registrationcomplianceregulatory submissionspharmacovigilanceanalytical skillsattention to detail
Soft skills
communicationindependenceorganizational skills
Certifications
Bachelor’s degree in PharmacyBachelor’s degree in PharmacologyBachelor’s degree in Life SciencesMaster’s degree in PharmacyMaster’s degree in PharmacologyMaster’s degree in Life Sciences