Regulatory Affairs Specialist
3 weeks ago
About the Role
We are seeking a skilled Regulatory Affairs Specialist to support our team in ensuring compliance with regulatory requirements for new products, license renewals, and variations. The successful candidate will have a strong background in regulatory planning and experience with regional regulatory affairs. Key responsibilities include:
- Develop and implement regulatory strategies for new products and variations,
- Prepare and submit regulatory documents, including license renewals and variations,
- Collaborate with cross-functional teams to ensure regulatory compliance and influence regulatory decisions.
About the Department
The Clinical Medical Regulatory and Quality (CMRQ) team at Novo Nordisk is committed to bringing our products to market with speed and quality. We are a diverse and inclusive team that values creativity, active thinking, and collaboration. Our mission is to apply scientific principles to communicate the benefits of our products to customers.
Requirements
- Graduate degree in a relevant field, such as pharmacy, pharmacology, or biology,
- Fluency in both written and spoken English,
- At least 3 years of experience in the pharmaceutical industry or related fields, with a minimum of 1 year in regulatory affairs or a medical department.
Working at Novo Nordisk
We recognize that being the best company in the world is no longer enough. We aspire to be the best company for the world, and we believe this is only possible with talented employees from diverse backgrounds. We are committed to creating an inclusive culture that values diversity, equality, and opportunity for all. We are happy to discuss flexible working arrangements, subject to business needs.
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