Regulatory Affairs Manager
2 weeks ago
About the Role
We are seeking a highly motivated and experienced Regulatory Affairs professional to join our team at Novo Nordisk A/S. As a key member of our Clinical Medical Regulatory and Quality department, you will play a critical role in driving innovation and transforming the treatment paradigm for chronic diseases.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with international regulations and guidelines.
- Prepare and submit regulatory documentation, including submissions and approvals for new products, license renewal, variation, and registration.
- Collaborate with cross-functional teams to ensure regulatory influence and compliance.
- Provide guidance and support to team members on regulatory affairs and compliance matters.
- Stay up-to-date with changes in regulatory requirements and guidelines, and ensure that our processes and procedures are aligned.
Requirements
- Relevant graduate-level degree, e.g., Pharmacy, Pharmacology, Biology.
- Fluency in both written and spoken English.
- Minimum 3 years of experience in the pharmaceutical industry or related industries, such as medical devices or healthcare.
- Experience in regulatory affairs or medical departments, with a preference for international pharmaceutical companies.
- Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders.
About Us
Novo Nordisk A/S is a global healthcare company dedicated to driving innovation and improving the lives of patients worldwide. Our Clinical Medical Regulatory and Quality department is committed to bringing our products to market with the fastest speed and top quality, while applying the most scientific approach to communicate our products' benefits to customers.
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