Regulatory Affairs Specialist responsible for leading regulatory strategies for Novo Nordisk’s Obesity and Diabetes portfolio. Collaborate with cross-functional teams and health authorities for submissions and documentation.
Responsibilities
Developing regulatory strategies and lead their execution via interaction with cross-functional teams
Leading major submission tracks such as briefing packages for meetings with Health Authorities, clinical trial applications, and global submission strategies
Working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
Reporting to the head of the department and taking active part in department related activities, including improvement projects across RA.
Requirements
A Master’s degree or Ph.D. in science, pharmaceutical or health science
Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
Excellent project management skills and ability to cooperate at any organizational level
Change-oriented approach and a willingness to experiment
Strong communication skills in verbal and written English.
International Compliance Administrator supporting RM team with international compliance registrations and administrative tasks at Valpak, UK's leading environmental compliance provider.
Manager, Compliance overseeing federal clients' FOIA compliance and federal contracting adherence. Leading strategic guidance and compliance operations with a focus on effective audits and training.
Compliance Officer conducting onsite and remote branch examinations at Aviso Wealth. Join our dynamic team improving the financial well - being of Canadians through compliance oversight.
Group Regulatory Policy Manager overseeing regulatory policy strategy and advocacy at Lloyds Banking Group. Collaborating across teams to enhance regulatory insights and communications.
Compliance Assistant Manager supporting regulatory and business change activities at Western Alliance Bank. This role involves oversight, guidance, and collaboration across multiple business lines.
Global Regulatory Lead managing regulatory strategies and compliance for new pharmaceutical products. Collaborating with global teams and authorities throughout the product lifecycle.
Manager of Software Audit overseeing software license compliance and SAM capabilities at Gap Inc. Collaborating cross - functionally to analyze software usage and enforce adherence to licensing requirements.
Security Worker responsible for maintaining security at Kauffman Stadium. Conducting patrols, inspections, and collaborating with local authorities for safety management.
Director of US Regulatory Affairs leading end - to - end labeling processes in a biopharmaceutical company. Collaborating with cross - functional teams ensuring compliance in labeling development and management.