Regulatory Affairs Specialist
Há 2 dias
We are seeking a highly skilled Regulatory Affairs Analyst to join our team at Novo Nordisk. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the safety and efficacy of our products.
Key Responsibilities- Monitor the local regulatory environment to ensure compliance and support NDA and LCM licence submissions and approvals.
- Develop local labelling and ensure regulatory compliance in promotional materials, maintaining records on legislation, regulations, and guidelines.
- Conduct research on submission requirements, provide information on local regulatory needs to other departments, and assist in monitoring and reporting project timelines.
- Draft routine correspondence to regulatory agencies and manage regulatory archiving in accordance with local legislation and SOPs.
- Collaborate with other departments, maintaining open communication and cooperation.
- Follow RA audits and manufacturing site inspections to ensure regulatory compliance.
- Bachelor's degree in health-related areas (e.g., Medicine, Pharmacy, Biology, Biomedicine).
- Advanced level of English.
- Experience with regulatory authorities or at an international pharmaceutical manufacturer.
- Experience in developing labelling materials and reviewing/approving promotional materials and familiarity with regulatory submission processes and requirements.
We have a collaborative, knowledge-sharing, and inclusive culture in Regulatory Affairs. Our approach, culture, and ways of working empower us to develop and grow as individuals and to improve and optimise our processes as a team – making our work and efforts valuable and impactful to both Novo Nordisk and the lives of our patients worldwide.
Working at Novo NordiskWe don't wait for change. We drive change. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection.
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