Regulatory Affairs Specialist
1 week ago
Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? We're seeking a highly motivated and experienced Regulatory Affairs professional to join our team at Novo Nordisk A/S.
The Role
- Develop and implement regulatory strategies to ensure compliance with global regulations and guidelines.
- Collaborate with cross-functional teams to ensure timely and successful product submissions and approvals.
- Provide regulatory expertise and support to ensure the quality and integrity of our products.
- Stay up-to-date with changing regulatory requirements and ensure our products meet the highest standards.
- Contribute to the development of regulatory policies and procedures to ensure compliance and efficiency.
Requirements
- Relevant graduate degree in a field such as pharmacy, pharmacology, or biology.
- Fluency in English, both written and spoken.
- Minimum 3 years of experience in the pharmaceutical industry or related field.
- Proven track record of success in regulatory affairs, with experience in international pharmaceutical companies.
- Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
About the Department
Our Clinical Medical Regulatory and Quality (CMRQ) department is committed to bringing our products to the Chinese market with speed and quality, while applying the most scientific approach to communicate our products' benefits to customers. We have 6 teams in CMRQ, each with a unique focus, including portfolio evaluation and overall strategy, new product approval, license maintenance, product localization, clinical evidence trial operation, and multiple stakeholders' engagement.
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