Novo Nordisk एक वैश्विक स्वास्थ्य सेवा कंपनी है, जो मोटापे और मधुमेह के उपचार विकसित करने पर केंद्रित है और इन क्षेत्रों में 25 से अधिक वर्षों से अनुसंधान कर रही है। 1923 में स्थापित यह कंपनी जीवन के विभिन्न चरणों में रोगियों की सहायता के लिए बनाई गई दवाओं का उत्पादन करती है और नकली दवाओं से निपटने के प्रयासों सहित अपने उत्पादों की सुरक्षा और विश्वसनीयता को मजबूत करने के लिए काम करती है। इसका कार्य औषधीय अनुसंधान, रोगी देखभाल और आवश्यक उपचार तक पहुंच में सुधार के व्यापक प्रयासों तक फैला हुआ है।
Senior Regulatory Affairs Professional, Novo Nordisk
Lead global regulatory submissions, product labelling and Health Authority strategy for Novo Nordisk medicines. Guide products through development, approval and commercial lifecycle activities across major markets.
विवरण
- Lead global regulatory strategy for Novo Nordisk products from development through approval and lifecycle management.
- Manage regulatory submissions and engagement with Health Authorities.
- Shape core product labelling to communicate key differentiators.
- Represent Regulatory Affairs on the Global Project Team.
- Use regulatory intelligence to inform strategy and planning.
- Keep the submission plan current in Vault RIM.
- Manage regulatory files—including MAA/NDA/BLA, CTA/IND, device files, PIP/PSP, DSUR/PSUR/RMP, renewals and post-approval changes—from preparation through approval and archiving.
- Plan and lead formal Health Authority meetings, including requests, briefing packages, rehearsals and minutes.
- Develop tCCDS/CCDS, EU and national labelling for new products; support US labelling and maintain labels throughout the product lifecycle.
- Lead regulatory work on the Global Project Team and shape development paths for governance review.
- Chair the RQC Matrix Team, set agendas, prepare input for GPT, GRPT and GRB, and coordinate contributions from CMC, device and labelling sub-teams.
- Advise cross-functional clinical expert groups on regulatory matters, including China-related work.
- Lead worldwide NDA roll-out.
- Set regulatory strategies for commercial products, covering label changes, licence maintenance and other lifecycle activities.
- Cover for other Global Regulatory Leads as needed.
- Raise progress updates, risks and issues early to support timely team decisions.
- Support onboarding, job-shadowing, mentoring and team engagement.
आवश्यकताएँ
- Degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences or a related scientific discipline.
- 12–15+ years of experience in regulatory affairs or closely related work across the pharmaceutical R&D value chain.
- In-depth knowledge of regulatory science and requirements in the EU, US, China, Japan and other regions.
- Practical submission experience in the EU, US, China and Japan.
- Demonstrated experience in lifecycle management, label development, Health Authority interactions, device development and regulatory intelligence.
- Strong project management skills.
- Strong negotiation, stakeholder management and networking skills.
- Ability to build trust across functions and cultures.
- Thorough understanding of the relevant therapy area.
- Proficiency in written and spoken English.
- Ability to adapt as priorities change, identify problems early and make well-founded decisions.
लाभ
- Inclusive recruitment and equal opportunity for all applicants.
- Opportunities to develop skills across the R&D value chain.
- Ownership of professional development.
- Onboarding, job-shadowing and mentoring opportunities.
- Opportunities to contribute to team and department engagement.