Novo Nordisk ir globāls veselības aprūpes uzņēmums, kas koncentrējas uz aptaukošanās un diabēta ārstēšanas līdzekļu izstrādi un kuram šajās jomās ir vairāk nekā 25 gadu pētniecības pieredze. Uzņēmums, kas dibināts 1923. gadā, ražo zāles, kuru mērķis ir atbalstīt pacientus dažādos dzīves posmos, un strādā pie savu produktu drošuma un uzticamības stiprināšanas, tostarp cīnoties pret viltotām zālēm. Tā darbība aptver farmaceitisko pētniecību, pacientu aprūpi un plašākus centienus uzlabot būtiskas ārstēšanas pieejamību.
Senior Regulatory Affairs Professional — Novo Nordisk
Lead global drug submissions and Health Authority engagement at Novo Nordisk. Shape lifecycle management, labelling, and regulatory strategy with cross-functional teams.
Dānija651 000 kr – 956 900 kr / gads
KlātienēPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuAtbilstībaApraksts
- Support global drug development and lifecycle management through regulatory planning and execution.
- Coordinate worldwide marketing authorisation, clinical trial, and lifecycle submissions.
- Use regulatory intelligence to shape submission strategies, plans, document structures, and schedules.
- Prepare regulatory dossiers and coordinate their drafting, review, and filing.
- Oversee Health Authority responses, commitments, and subsequent actions.
- Arrange and support Health Authority meetings, from requests and briefing materials to rehearsals and records.
- Create and maintain core labelling, including the Company Core Data Sheet and European product information.
- Help set global regulatory direction and improve processes, methods, and approaches.
- Advise stakeholders on regulatory matters and mentor junior colleagues as appropriate.
- Work across clinical reporting, medical and translational science, clinical operations, global safety, medical affairs, commercial, legal, quality, and regulatory affairs.
- Work with agencies including the EMA, FDA, Japan’s PMDA, and other regulators worldwide.
- Build agreement across disciplines, teams, and regions to support stakeholder decisions.
Prasības
- A life sciences master’s degree and around 5–7 years of relevant experience, or a PhD and around 3–4 years of experience.
- A life sciences bachelor’s degree and around 8–11 years of relevant experience, or equivalent practical knowledge.
- Experience with regulatory filings and requirements in at least one major market, such as the EU, US, China, or Japan.
- Knowledge of early- or late-stage drug development, lifecycle management, labelling, or Health Authority engagement.
- Strong spoken and written English.
- Skill in interpreting complex scientific and regulatory material and explaining it clearly to varied audiences.
- Able to work autonomously, set priorities, and manage multiple complex deliverables.
- Experience in clinical development, pharmacovigilance, medical devices, regulatory intelligence, market access, or project management is an advantage.
Priekšrocības
- Short-term and/or long-term incentives may be offered.
- Other employee benefits depend on role level, location, function, and relevant market benchmarks.
- A culture that values diverse perspectives, shared purpose, and mutual respect.