Senior Regulatory Affairs Professional
2 weeks ago
We are seeking a highly skilled Senior Regulatory Affairs Professional to join our team at Novo Nordisk.
About the RoleThe successful candidate will be responsible for providing strategic regulatory guidance and support to ensure compliance with all relevant regulations and guidelines. This will include planning and executing regulatory submissions, managing relationships with regulatory agencies, and ensuring that all products meet the required regulatory standards.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with relevant regulations and guidelines;
- Prepare and submit regulatory documents and applications, including marketing authorizations and variations;
- Manage relationships with regulatory agencies, including responding to queries and resolving issues;
- Ensure that all products meet the required regulatory standards, including conducting gap analyses and implementing corrective actions;
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Quality Assurance, to ensure regulatory compliance throughout the product lifecycle.
To be successful in this role, you will need:
- A relevant graduate degree, such as Pharmacy, Pharmacology, or Biology;
- Fluency in both written and spoken English;
- A minimum of 4+ years' experience in Regulatory Affairs in the pharmaceutical industry;
- Strong analytical and problem-solving skills, with the ability to interpret complex regulations and guidelines;
- Excellent communication and interpersonal skills, with the ability to work effectively with colleagues and external stakeholders;
- Knowledge of regulatory requirements and guidelines, including ICH, GMP, and GCP.
We offer a competitive salary package, including an estimated $120,000 - $150,000 per annum, depending on location and experience. We also offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
About UsNovo Nordisk is a global healthcare company with a commitment to creating a better world for people with diabetes and other chronic diseases. We are a leader in innovation, with a portfolio of medicines and devices that improve the lives of millions of people around the world. Our company values include integrity, courage, and respect, and we are committed to creating a diverse and inclusive workplace culture.
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